gabapentin

Generic: gabapentin

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler laurus labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-973
Product ID 42385-973_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217546
Listing Expiration 2026-12-31
Marketing Start 2023-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385973
Hyphenated Format 42385-973

Supplemental Identifiers

RxCUI
310430 310431 310432 310433 310434
UPC
0342385980301
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 ANDA217546 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42385-973-01)
  • 500 CAPSULE in 1 BOTTLE (42385-973-05)
  • 1000 CAPSULE in 1 BOTTLE (42385-973-11)
  • 30 CAPSULE in 1 BOTTLE (42385-973-30)
  • 10 BLISTER PACK in 1 CARTON (42385-973-72) / 10 CAPSULE in 1 BLISTER PACK
  • 90 CAPSULE in 1 BOTTLE (42385-973-90)
source: ndc

Packages (6)

42385-973-01 100 CAPSULE in 1 BOTTLE (42385-973-01) 42385-973-05 500 CAPSULE in 1 BOTTLE (42385-973-05) 42385-973-11 1000 CAPSULE in 1 BOTTLE (42385-973-11) 42385-973-30 30 CAPSULE in 1 BOTTLE (42385-973-30) 42385-973-72 10 BLISTER PACK in 1 CARTON (42385-973-72) / 10 CAPSULE in 1 BLISTER PACK 42385-973-90 90 CAPSULE in 1 BOTTLE (42385-973-90)

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": "7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d", "openfda": {"nui": ["N0000008486"], "upc": ["0342385980301"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432", "310433", "310434"], "spl_set_id": ["07aa1bcc-df05-44fa-92d4-63894e0e6cd6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42385-973-01)", "package_ndc": "42385-973-01", "marketing_start_date": "20230513"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42385-973-05)", "package_ndc": "42385-973-05", "marketing_start_date": "20230513"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (42385-973-11)", "package_ndc": "42385-973-11", "marketing_start_date": "20230513"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42385-973-30)", "package_ndc": "42385-973-30", "marketing_start_date": "20230513"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42385-973-72)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "42385-973-72", "marketing_start_date": "20230513"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (42385-973-90)", "package_ndc": "42385-973-90", "marketing_start_date": "20230513"}], "brand_name": "Gabapentin", "product_id": "42385-973_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42385-973", "generic_name": "Gabapentin", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA217546", "marketing_category": "ANDA", "marketing_start_date": "20230513", "listing_expiration_date": "20261231"}