gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

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

gabapentin 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-198
Product ID 65862-198_7a45ad84-02a4-442d-8401-1a1495d084fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078787
Listing Expiration 2026-12-31
Marketing Start 2008-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862198
Hyphenated Format 65862-198

Supplemental Identifiers

RxCUI
310430 310431 310432
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 ANDA078787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (65862-198-01)
  • 500 CAPSULE in 1 BOTTLE (65862-198-05)
  • 10 BLISTER PACK in 1 CARTON (65862-198-10) / 10 CAPSULE in 1 BLISTER PACK
  • 180 CAPSULE in 1 BOTTLE (65862-198-18)
  • 270 CAPSULE in 1 BOTTLE (65862-198-27)
  • 90 CAPSULE in 1 BOTTLE (65862-198-90)
  • 1000 CAPSULE in 1 BOTTLE (65862-198-99)
source: ndc

Packages (7)

65862-198-01 100 CAPSULE in 1 BOTTLE (65862-198-01) 65862-198-05 500 CAPSULE in 1 BOTTLE (65862-198-05) 65862-198-10 10 BLISTER PACK in 1 CARTON (65862-198-10) / 10 CAPSULE in 1 BLISTER PACK 65862-198-18 180 CAPSULE in 1 BOTTLE (65862-198-18) 65862-198-27 270 CAPSULE in 1 BOTTLE (65862-198-27) 65862-198-90 90 CAPSULE in 1 BOTTLE (65862-198-90) 65862-198-99 1000 CAPSULE in 1 BOTTLE (65862-198-99)

Ingredients (1)

gabapentin (100 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": "7a45ad84-02a4-442d-8401-1a1495d084fa", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["1a619a14-0b63-4cba-80e7-474c9a1c90b9"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65862-198-01)", "package_ndc": "65862-198-01", "marketing_start_date": "20080131"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-198-05)", "package_ndc": "65862-198-05", "marketing_start_date": "20080131"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-198-10)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "65862-198-10", "marketing_start_date": "20080131"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (65862-198-18)", "package_ndc": "65862-198-18", "marketing_start_date": "20210429"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (65862-198-27)", "package_ndc": "65862-198-27", "marketing_start_date": "20210429"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65862-198-90)", "package_ndc": "65862-198-90", "marketing_start_date": "20210429"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (65862-198-99)", "package_ndc": "65862-198-99", "marketing_start_date": "20080131"}], "brand_name": "Gabapentin", "product_id": "65862-198_7a45ad84-02a4-442d-8401-1a1495d084fa", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65862-198", "generic_name": "Gabapentin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "100 mg/1"}], "application_number": "ANDA078787", "marketing_category": "ANDA", "marketing_start_date": "20080131", "listing_expiration_date": "20261231"}