gabapentin

Generic: gabapentin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-185
Product ID 71610-185_e1f89ae6-021d-4fcd-ad58-27f2be19fd6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090705
Listing Expiration 2026-12-31
Marketing Start 2018-09-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610185
Hyphenated Format 71610-185

Supplemental Identifiers

RxCUI
310431
UNII
6CW7F3G59X
NUI
N0000008486

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 gabapentin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number ANDA090705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-185-30)
  • 60 CAPSULE in 1 BOTTLE (71610-185-53)
  • 90 CAPSULE in 1 BOTTLE (71610-185-60)
  • 120 CAPSULE in 1 BOTTLE (71610-185-70)
  • 180 CAPSULE in 1 BOTTLE (71610-185-80)
  • 270 CAPSULE in 1 BOTTLE (71610-185-92)
  • 360 CAPSULE in 1 BOTTLE (71610-185-94)
source: ndc

Packages (7)

71610-185-30 30 CAPSULE in 1 BOTTLE (71610-185-30) 71610-185-53 60 CAPSULE in 1 BOTTLE (71610-185-53) 71610-185-60 90 CAPSULE in 1 BOTTLE (71610-185-60) 71610-185-70 120 CAPSULE in 1 BOTTLE (71610-185-70) 71610-185-80 180 CAPSULE in 1 BOTTLE (71610-185-80) 71610-185-92 270 CAPSULE in 1 BOTTLE (71610-185-92) 71610-185-94 360 CAPSULE in 1 BOTTLE (71610-185-94)

Ingredients (1)

gabapentin (300 mg/1)

Linked Drug Pages (1)

GABAPENTIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e1f89ae6-021d-4fcd-ad58-27f2be19fd6e", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["a900bafb-8f49-4a01-ba7f-4fb228ec0253"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-185-30)", "package_ndc": "71610-185-30", "marketing_start_date": "20181102"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-185-53)", "package_ndc": "71610-185-53", "marketing_start_date": "20181102"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-185-60)", "package_ndc": "71610-185-60", "marketing_start_date": "20181112"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-185-70)", "package_ndc": "71610-185-70", "marketing_start_date": "20181102"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-185-80)", "package_ndc": "71610-185-80", "marketing_start_date": "20181112"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (71610-185-92)", "package_ndc": "71610-185-92", "marketing_start_date": "20181112"}, {"sample": false, "description": "360 CAPSULE in 1 BOTTLE (71610-185-94)", "package_ndc": "71610-185-94", "marketing_start_date": "20181112"}], "brand_name": "GABAPENTIN", "product_id": "71610-185_e1f89ae6-021d-4fcd-ad58-27f2be19fd6e", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-185", "generic_name": "GABAPENTIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA090705", "marketing_category": "ANDA", "marketing_start_date": "20180913", "listing_expiration_date": "20261231"}