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 400 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1469
Product ID 70518-1469_490ec676-81a2-6ba1-e063-6394a90a5039
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090858
Listing Expiration 2027-12-31
Marketing Start 2018-10-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181469
Hyphenated Format 70518-1469

Supplemental Identifiers

RxCUI
310432
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
  • 400 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (70518-1469-0)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-1)
  • 100 POUCH in 1 BOX (70518-1469-4) / 1 CAPSULE in 1 POUCH (70518-1469-5)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-6)
source: ndc

Packages (4)

70518-1469-0 30 CAPSULE in 1 BLISTER PACK (70518-1469-0) 70518-1469-1 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-1) 70518-1469-4 100 POUCH in 1 BOX (70518-1469-4) / 1 CAPSULE in 1 POUCH (70518-1469-5) 70518-1469-6 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-6)

Ingredients (1)

gabapentin (400 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": "490ec676-81a2-6ba1-e063-6394a90a5039", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310432"], "spl_set_id": ["78445dbf-c7cd-419f-a7be-72821e496628"], "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 (70518-1469-0)", "package_ndc": "70518-1469-0", "marketing_start_date": "20181005"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-1)", "package_ndc": "70518-1469-1", "marketing_start_date": "20190709"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-1469-4)  / 1 CAPSULE in 1 POUCH (70518-1469-5)", "package_ndc": "70518-1469-4", "marketing_start_date": "20181005"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (70518-1469-6)", "package_ndc": "70518-1469-6", "marketing_start_date": "20230912"}], "brand_name": "Gabapentin", "product_id": "70518-1469_490ec676-81a2-6ba1-e063-6394a90a5039", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-1469", "generic_name": "Gabapentin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA090858", "marketing_category": "ANDA", "marketing_start_date": "20181005", "listing_expiration_date": "20271231"}