gabapentin

Generic: gabapentin

Labeler: acella pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler acella pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
Acella Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42192-608
Product ID 42192-608_42b42328-c02f-5413-e063-6394a90ace67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076403
Listing Expiration 2026-12-31
Marketing Start 2012-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42192608
Hyphenated Format 42192-608

Supplemental Identifiers

RxCUI
283523
UPC
0342192608160
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 gabapentin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number ANDA076403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 5 mL in 1 CUP, UNIT-DOSE (42192-608-05)
  • 6 mL in 1 CUP, UNIT-DOSE (42192-608-06)
  • 470 mL in 1 BOTTLE (42192-608-16)
  • 40 CUP, UNIT-DOSE in 1 BOX (42192-608-40) / 6 mL in 1 CUP, UNIT-DOSE
  • 40 CUP, UNIT-DOSE in 1 BOX (42192-608-45) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (5)

42192-608-05 5 mL in 1 CUP, UNIT-DOSE (42192-608-05) 42192-608-06 6 mL in 1 CUP, UNIT-DOSE (42192-608-06) 42192-608-16 470 mL in 1 BOTTLE (42192-608-16) 42192-608-40 40 CUP, UNIT-DOSE in 1 BOX (42192-608-40) / 6 mL in 1 CUP, UNIT-DOSE 42192-608-45 40 CUP, UNIT-DOSE in 1 BOX (42192-608-45) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

gabapentin (250 mg/5mL)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42b42328-c02f-5413-e063-6394a90ace67", "openfda": {"nui": ["N0000008486"], "upc": ["0342192608160"], "unii": ["6CW7F3G59X"], "rxcui": ["283523"], "spl_set_id": ["3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 CUP, UNIT-DOSE (42192-608-05)", "package_ndc": "42192-608-05", "marketing_start_date": "20190816"}, {"sample": false, "description": "6 mL in 1 CUP, UNIT-DOSE (42192-608-06)", "package_ndc": "42192-608-06", "marketing_start_date": "20190816"}, {"sample": false, "description": "470 mL in 1 BOTTLE (42192-608-16)", "package_ndc": "42192-608-16", "marketing_start_date": "20121001"}, {"sample": false, "description": "40 CUP, UNIT-DOSE in 1 BOX (42192-608-40)  / 6 mL in 1 CUP, UNIT-DOSE", "package_ndc": "42192-608-40", "marketing_start_date": "20190816"}, {"sample": false, "description": "40 CUP, UNIT-DOSE in 1 BOX (42192-608-45)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "42192-608-45", "marketing_start_date": "20210505"}], "brand_name": "Gabapentin", "product_id": "42192-608_42b42328-c02f-5413-e063-6394a90ace67", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42192-608", "generic_name": "gabapentin", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "250 mg/5mL"}], "application_number": "ANDA076403", "marketing_category": "ANDA", "marketing_start_date": "20121001", "listing_expiration_date": "20261231"}