gabapentin

Generic: gabapentin

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler direct rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 61919-640
Product ID 61919-640_47e158f3-f67b-74b2-e063-6394a90ac498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090007
Listing Expiration 2027-12-31
Marketing Start 2015-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919640
Hyphenated Format 61919-640

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 ANDA090007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (61919-640-30)
source: ndc

Packages (1)

61919-640-30 30 CAPSULE in 1 BOTTLE (61919-640-30)

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": "47e158f3-f67b-74b2-e063-6394a90ac498", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["29a70e2d-d3fd-4e32-95dd-7ee721d87388"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (61919-640-30)", "package_ndc": "61919-640-30", "marketing_start_date": "20190409"}], "brand_name": "GABAPENTIN", "product_id": "61919-640_47e158f3-f67b-74b2-e063-6394a90ac498", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "61919-640", "generic_name": "GABAPENTIN", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA090007", "marketing_category": "ANDA", "marketing_start_date": "20151230", "listing_expiration_date": "20271231"}