gabapentin

Generic: gabapentin

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-091
Product ID 31722-091_360950f4-eef0-54cb-e063-6394a90aa5d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218075
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722091
Hyphenated Format 31722-091

Supplemental Identifiers

RxCUI
1806380 1806382
UPC
0331722091909
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 ANDA218075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-091-90)
source: ndc

Packages (1)

31722-091-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-091-90)

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": "360950f4-eef0-54cb-e063-6394a90aa5d6", "openfda": {"nui": ["N0000008486"], "upc": ["0331722091909"], "unii": ["6CW7F3G59X"], "rxcui": ["1806380", "1806382"], "spl_set_id": ["0ce53f62-1738-43f4-9a2e-c5dc42a91d09"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-091-90)", "package_ndc": "31722-091-90", "marketing_start_date": "20240226"}], "brand_name": "GABAPENTIN", "product_id": "31722-091_360950f4-eef0-54cb-e063-6394a90aa5d6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "31722-091", "generic_name": "GABAPENTIN", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA218075", "marketing_category": "ANDA", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}