gabapentin

Generic: gabapentin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

gabapentin 600 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-127
Product ID 72789-127_4af71629-cd0b-2e7c-e063-6394a90a2eab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078926
Listing Expiration 2027-12-31
Marketing Start 2012-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789127
Hyphenated Format 72789-127

Supplemental Identifiers

RxCUI
310433
UPC
0372789127903
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 ANDA078926 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-90)
source: ndc

Packages (2)

72789-127-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-30) 72789-127-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-90)

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": "4af71629-cd0b-2e7c-e063-6394a90a2eab", "openfda": {"nui": ["N0000008486"], "upc": ["0372789127903"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["81774da8-cb1d-4c7d-8550-35396850d5ff"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-30)", "package_ndc": "72789-127-30", "marketing_start_date": "20200925"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-90)", "package_ndc": "72789-127-90", "marketing_start_date": "20221201"}], "brand_name": "Gabapentin", "product_id": "72789-127_4af71629-cd0b-2e7c-e063-6394a90a2eab", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72789-127", "generic_name": "Gabapentin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA078926", "marketing_category": "ANDA", "marketing_start_date": "20121016", "listing_expiration_date": "20271231"}