gabapentin

Generic: gabapentin

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler quality care products, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-049
Product ID 83008-049_d90e8e46-4db4-4761-a13d-e22266fba7a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204989
Marketing Start 2023-12-21
Marketing End 2026-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008049
Hyphenated Format 83008-049

Supplemental Identifiers

RxCUI
310432
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 ANDA204989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (83008-049-60)
source: ndc

Packages (1)

83008-049-60 60 CAPSULE in 1 BOTTLE, PLASTIC (83008-049-60)

Ingredients (1)

gabapentin (400 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": "d90e8e46-4db4-4761-a13d-e22266fba7a3", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310432"], "spl_set_id": ["dea03ea5-1806-44ab-84e3-42a85f0db982"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (83008-049-60)", "package_ndc": "83008-049-60", "marketing_end_date": "20260731", "marketing_start_date": "20231221"}], "brand_name": "Gabapentin", "product_id": "83008-049_d90e8e46-4db4-4761-a13d-e22266fba7a3", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "83008-049", "generic_name": "Gabapentin", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA204989", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20231221"}