gabapentin

Generic: gabapentin

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-330
Product ID 16714-330_e1bc9060-641c-4196-acfd-676a3d263fed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200651
Listing Expiration 2026-12-31
Marketing Start 2011-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714330
Hyphenated Format 16714-330

Supplemental Identifiers

RxCUI
310433 310434
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 ANDA200651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-330-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16714-330-02)
source: ndc

Packages (2)

16714-330-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-330-01) 16714-330-02 500 TABLET, FILM COATED in 1 BOTTLE (16714-330-02)

Ingredients (1)

gabapentin (600 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": "e1bc9060-641c-4196-acfd-676a3d263fed", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-330-01)", "package_ndc": "16714-330-01", "marketing_start_date": "20111006"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16714-330-02)", "package_ndc": "16714-330-02", "marketing_start_date": "20111006"}], "brand_name": "Gabapentin", "product_id": "16714-330_e1bc9060-641c-4196-acfd-676a3d263fed", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16714-330", "generic_name": "Gabapentin", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA200651", "marketing_category": "ANDA", "marketing_start_date": "20111006", "listing_expiration_date": "20261231"}