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 SOLUTION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3708
Product ID 70518-3708_3f290872-8935-79f1-e063-6394a90a3e67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076403
Listing Expiration 2026-12-31
Marketing Start 2023-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183708
Hyphenated Format 70518-3708

Supplemental Identifiers

RxCUI
283523
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 ANDA076403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3708-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-3708-1)
source: ndc

Packages (1)

70518-3708-0 10 CUP, UNIT-DOSE in 1 BOX (70518-3708-0) / 10 mL in 1 CUP, UNIT-DOSE (70518-3708-1)

Ingredients (1)

gabapentin (250 mg/5mL)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f290872-8935-79f1-e063-6394a90a3e67", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["283523"], "spl_set_id": ["cfd8122f-8b23-42c1-97e8-43df98af88e0"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3708-0)  / 10 mL in 1 CUP, UNIT-DOSE (70518-3708-1)", "package_ndc": "70518-3708-0", "marketing_start_date": "20230411"}], "brand_name": "Gabapentin", "product_id": "70518-3708_3f290872-8935-79f1-e063-6394a90a3e67", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-3708", "generic_name": "gabapentin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "250 mg/5mL"}], "application_number": "ANDA076403", "marketing_category": "ANDA", "marketing_start_date": "20230411", "listing_expiration_date": "20261231"}