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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2356
Product ID 70518-2356_4a042552-afa0-b1d8-e063-6294a90abfad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200651
Listing Expiration 2027-12-31
Marketing Start 2019-10-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182356
Hyphenated Format 70518-2356

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2356-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-1)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-2)
source: ndc

Packages (3)

70518-2356-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2356-0) 70518-2356-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-1) 70518-2356-2 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-2)

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": "4a042552-afa0-b1d8-e063-6294a90abfad", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["5a78ab50-993d-4857-be10-be665e02b353"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2356-0)", "package_ndc": "70518-2356-0", "marketing_start_date": "20191009"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-1)", "package_ndc": "70518-2356-1", "marketing_start_date": "20191021"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2356-2)", "package_ndc": "70518-2356-2", "marketing_start_date": "20200513"}], "brand_name": "Gabapentin", "product_id": "70518-2356_4a042552-afa0-b1d8-e063-6294a90abfad", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-2356", "generic_name": "Gabapentin", "labeler_name": "REMEDYREPACK INC.", "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": "20191009", "listing_expiration_date": "20271231"}