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 70518-1760
Product ID 70518-1760_49654312-99dd-fc47-e063-6294a90afe78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090858
Listing Expiration 2027-12-31
Marketing Start 2019-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181760
Hyphenated Format 70518-1760

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
  • 30 CAPSULE in 1 BLISTER PACK (70518-1760-0)
  • 30 CAPSULE in 1 BLISTER PACK (70518-1760-4)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-5)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-6)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-7)
  • 120 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-8)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-9)
source: ndc

Packages (7)

Ingredients (1)

gabapentin (300 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "49654312-99dd-fc47-e063-6294a90afe78", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["d06380d0-c894-427e-b13e-5a8f9eb86a34"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-1760-0)", "package_ndc": "70518-1760-0", "marketing_start_date": "20190101"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-1760-4)", "package_ndc": "70518-1760-4", "marketing_start_date": "20210806"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-5)", "package_ndc": "70518-1760-5", "marketing_start_date": "20210817"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-6)", "package_ndc": "70518-1760-6", "marketing_start_date": "20211008"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-7)", "package_ndc": "70518-1760-7", "marketing_start_date": "20211018"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-8)", "package_ndc": "70518-1760-8", "marketing_start_date": "20211101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (70518-1760-9)", "package_ndc": "70518-1760-9", "marketing_start_date": "20211229"}], "brand_name": "Gabapentin", "product_id": "70518-1760_49654312-99dd-fc47-e063-6294a90afe78", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-1760", "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": "20190101", "listing_expiration_date": "20271231"}