gabapentin

Generic: gabapentin

Labeler: time cap laboratories, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler time cap laboratories, inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-607
Product ID 49483-607_39a5daea-e195-c00b-e063-6394a90a42a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090007
Listing Expiration 2026-12-31
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 49483607
Hyphenated Format 49483-607

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0349483605105 0349483605013 0349483607109 0349483606102 0349483607017 0349483606010
UNII
6CW7F3G59X
NUI
N0000008486

Packaging Origin

Original Packager
true

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
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (49483-607-01)
  • 1000 CAPSULE in 1 BOTTLE (49483-607-10)
  • 500 CAPSULE in 1 BOTTLE (49483-607-50)
source: ndc

Packages (3)

49483-607-01 100 CAPSULE in 1 BOTTLE (49483-607-01) 49483-607-10 1000 CAPSULE in 1 BOTTLE (49483-607-10) 49483-607-50 500 CAPSULE in 1 BOTTLE (49483-607-50)

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": "39a5daea-e195-c00b-e063-6394a90a42a1", "openfda": {"nui": ["N0000008486"], "upc": ["0349483605105", "0349483605013", "0349483607109", "0349483606102", "0349483607017", "0349483606010"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["08880902-bd44-41b6-866b-2cbad4c3f2b1"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (49483-607-01)", "package_ndc": "49483-607-01", "marketing_start_date": "20151230"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (49483-607-10)", "package_ndc": "49483-607-10", "marketing_start_date": "20210417"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (49483-607-50)", "package_ndc": "49483-607-50", "marketing_start_date": "20151230"}], "brand_name": "GABAPENTIN", "product_id": "49483-607_39a5daea-e195-c00b-e063-6394a90a42a1", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "49483-607", "generic_name": "GABAPENTIN", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA090007", "marketing_category": "ANDA", "marketing_start_date": "20151230", "listing_expiration_date": "20261231"}