neurontin

Generic: gabapentin

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name neurontin
Generic Name gabapentin
Labeler viatris specialty llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-282
Product ID 58151-282_2f08fde1-cc40-43e1-b2ea-95b44505dc19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020235
Listing Expiration 2027-12-31
Marketing Start 2024-07-22

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151282
Hyphenated Format 58151-282

Supplemental Identifiers

RxCUI
105028 105029 105030 261280 261281 283523 310430 310431 310432 310433 310434 351973
UNII
6CW7F3G59X
NUI
N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name neurontin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number NDA020235 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING NEURONTIN (gabapentin) capsules, tablets, and oral solution are supplied as follows: 100 mg capsules: White hard gelatin capsules printed with “VLE” on the body and “Neurontin/100 mg” on the cap; available in: Bottles of 100: NDC 58151-281-01 300 mg capsules: Yellow hard gelatin capsules printed with “VLE” on the body and “Neurontin/300 mg” on the cap; available in: Bottles of 100: NDC 58151-282-01 400 mg capsules: Orange hard gelatin capsules printed with “VLE” on the body and “Neurontin/400 mg” on the cap; available in: Bottles of 100: NDC 58151-283-01 600 mg tablets: White elliptical film-coated scored tablets debossed with “NT” and “16” on one side; available in: Bottles of 100: NDC 58151-284-01 800 mg tablets: White elliptical film-coated scored tablets debossed with “NT” and “26” on one side; available in: Bottles of 100: NDC 58151-285-01 250 mg per 5 mL oral solution: Clear colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in: Bottles containing 470 mL: NDC 58151-290-35 Store NEURONTIN Tablets and Capsules at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store NEURONTIN Oral Solution refrigerated, 2°C to 8°C (36°F to 46°F).
  • PRINCIPAL DISPLAY PANEL – 100 mg ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 58151-281-01 Neurontin ® (gabapentin) capsules 100 mg 100 Capsules Rx only Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See package insert for full prescribing information. Each capsule contains 100 mg of gabapentin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. RUPJ281A Neurontin® (gabapentin) Capsules 100 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 300 mg ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 58151-282-01 Neurontin ® (gabapentin) capsules 300 mg 100 Capsules Rx only Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See package insert for full prescribing information. Each capsule contains 300 mg of gabapentin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. RUPJ282A Neurontin® (gabapentin) Capsules 300 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 400 mg ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 58151-283-01 Neurontin ® (gabapentin) capsules 400 mg 100 Capsules Rx only Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See package insert for full prescribing information. Each capsule contains 400 mg of gabapentin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. RUPJ283A Neurontin® (gabapentin) Capsules 400 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 600 mg ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 58151-284-01 Neurontin ® (gabapentin) tablets 600 mg 100 Tablets Rx only Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See package insert for full prescribing information. Each tablet contains 600 mg of gabapentin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. RUPJ284A Neurontin® (gabapentin) Capsules 600 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – 800 mg ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 58151-285-01 Neurontin ® (gabapentin) tablets 800 mg 100 Tablets Rx only Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See package insert for full prescribing information. Each tablet contains 800 mg of gabapentin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. RUPJ286A Neurontin® (gabapentin) Capsules 800 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL – Oral Solution, 250 mg/5 mL ALWAYS DISPENSE WITH MEDICATION GUIDE NDC 58151-290-35 Neurontin ® (gabapentin) oral solution 250 mg per 5 mL 470 mL Rx only Store refrigerated, 2°C to 8°C (36°F to 46°F). DOSAGE AND USE See accompanying prescribing information. Keep this and all drugs out of the reach of children. Each 5 mL of oral solution contains 250 mg of gabapentin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. NEURONTIN is a registered trademark of UPJOHN US 1 LLC, a Viatris Company. UPJ:290:1C:R1 Neurontin® (gabapentin) Oral Solution, 250 mg/5 mL Container Label
source: label

Packages (0)

No package records.

Ingredients (1)

gabapentin (300 mg/1)

Linked Drug Pages (1)

Neurontin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f08fde1-cc40-43e1-b2ea-95b44505dc19", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["105028", "105029", "105030", "261280", "261281", "283523", "310430", "310431", "310432", "310433", "310434", "351973"], "spl_set_id": ["97935fd9-1d4a-43b6-a5d9-de994591187b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Neurontin", "product_id": "58151-282_2f08fde1-cc40-43e1-b2ea-95b44505dc19", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "58151-282", "generic_name": "gabapentin", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neurontin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "NDA020235", "marketing_category": "NDA", "marketing_start_date": "20240722", "listing_expiration_date": "20271231"}