gabapentin

Generic: gabapentin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3329
Product ID 70518-3329_453a9c93-2298-5d8e-e063-6294a90af085
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090858
Listing Expiration 2026-12-31
Marketing Start 2022-01-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183329
Hyphenated Format 70518-3329

Supplemental Identifiers

RxCUI
310431
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
  • 100 POUCH in 1 BOX (70518-3329-0) / 1 CAPSULE in 1 POUCH (70518-3329-1)
  • 100 POUCH in 1 BOX (70518-3329-4) / 1 CAPSULE in 1 POUCH (70518-3329-5)
source: ndc

Packages (2)

70518-3329-0 100 POUCH in 1 BOX (70518-3329-0) / 1 CAPSULE in 1 POUCH (70518-3329-1) 70518-3329-4 100 POUCH in 1 BOX (70518-3329-4) / 1 CAPSULE in 1 POUCH (70518-3329-5)

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": "453a9c93-2298-5d8e-e063-6294a90af085", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["ddb3a54f-5224-4024-8804-b2a2f01d885e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-3329-0)  / 1 CAPSULE in 1 POUCH (70518-3329-1)", "package_ndc": "70518-3329-0", "marketing_start_date": "20220111"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3329-4)  / 1 CAPSULE in 1 POUCH (70518-3329-5)", "package_ndc": "70518-3329-4", "marketing_start_date": "20240717"}], "brand_name": "Gabapentin", "product_id": "70518-3329_453a9c93-2298-5d8e-e063-6294a90af085", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-3329", "generic_name": "Gabapentin", "labeler_name": "REMEDYREPACK 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": "20220111", "listing_expiration_date": "20261231"}