gabapentin

Generic: gabapentin

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler strides pharma science limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-869
Product ID 64380-869_979787f3-7230-4586-862f-5c05686b8a43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211314
Listing Expiration 2027-12-31
Marketing Start 2018-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380869
Hyphenated Format 64380-869

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0364380868064 0364380869061 0364380867067
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 ANDA211314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64380-869-06)
  • 500 CAPSULE in 1 BOTTLE (64380-869-07)
source: ndc

Packages (2)

64380-869-06 100 CAPSULE in 1 BOTTLE (64380-869-06) 64380-869-07 500 CAPSULE in 1 BOTTLE (64380-869-07)

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": "979787f3-7230-4586-862f-5c05686b8a43", "openfda": {"nui": ["N0000008486"], "upc": ["0364380868064", "0364380869061", "0364380867067"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["43b67ae3-ac6f-48f5-8788-9ead08376864"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64380-869-06)", "package_ndc": "64380-869-06", "marketing_start_date": "20181017"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (64380-869-07)", "package_ndc": "64380-869-07", "marketing_start_date": "20181017"}], "brand_name": "GABAPENTIN", "product_id": "64380-869_979787f3-7230-4586-862f-5c05686b8a43", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "64380-869", "generic_name": "gabapentin", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA211314", "marketing_category": "ANDA", "marketing_start_date": "20181017", "listing_expiration_date": "20271231"}