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 CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-673
Product ID 43063-673_36c0c1ca-8073-9d37-e063-6294a90a824f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090858
Listing Expiration 2026-12-31
Marketing Start 2011-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063673
Hyphenated Format 43063-673

Supplemental Identifiers

RxCUI
310431
UPC
0343063673607
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 ANDA090858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-30)
  • 45 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-45)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-60)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-90)
source: ndc

Packages (4)

43063-673-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-30) 43063-673-45 45 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-45) 43063-673-60 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-60) 43063-673-90 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-90)

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": "36c0c1ca-8073-9d37-e063-6294a90a824f", "openfda": {"nui": ["N0000008486"], "upc": ["0343063673607"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["330ddc5d-c67c-33dc-e054-00144ff88e88"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-30)", "package_ndc": "43063-673-30", "marketing_start_date": "20201005"}, {"sample": false, "description": "45 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-45)", "package_ndc": "43063-673-45", "marketing_start_date": "20201005"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-60)", "package_ndc": "43063-673-60", "marketing_start_date": "20201005"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (43063-673-90)", "package_ndc": "43063-673-90", "marketing_start_date": "20201005"}], "brand_name": "Gabapentin", "product_id": "43063-673_36c0c1ca-8073-9d37-e063-6294a90a824f", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43063-673", "generic_name": "Gabapentin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA090858", "marketing_category": "ANDA", "marketing_start_date": "20110129", "listing_expiration_date": "20261231"}