pregabalin

Generic: pregabalin

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler indoco remedies limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 150 mg/1

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-125
Product ID 14445-125_522b3d6c-10fb-4581-afb7-2e48150b6048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208113
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-05-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14445125
Hyphenated Format 14445-125

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UNII
55JG375S6M

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 pregabalin (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA208113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (14445-125-00)
  • 100 CAPSULE in 1 BLISTER PACK (14445-125-10)
  • 90 CAPSULE in 1 BOTTLE (14445-125-90)
source: ndc

Packages (3)

14445-125-00 1000 CAPSULE in 1 BOTTLE (14445-125-00) 14445-125-10 100 CAPSULE in 1 BLISTER PACK (14445-125-10) 14445-125-90 90 CAPSULE in 1 BOTTLE (14445-125-90)

Ingredients (1)

pregabalin (150 mg/1)

Linked Drug Pages (1)

pregabalin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "522b3d6c-10fb-4581-afb7-2e48150b6048", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["0a8d9e35-46fd-4c70-bb7f-4e8b754f2794"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (14445-125-00)", "package_ndc": "14445-125-00", "marketing_start_date": "20240906"}, {"sample": false, "description": "100 CAPSULE in 1 BLISTER PACK (14445-125-10)", "package_ndc": "14445-125-10", "marketing_start_date": "20240517"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (14445-125-90)", "package_ndc": "14445-125-90", "marketing_start_date": "20240517"}], "brand_name": "pregabalin", "product_id": "14445-125_522b3d6c-10fb-4581-afb7-2e48150b6048", "dosage_form": "CAPSULE", "product_ndc": "14445-125", "dea_schedule": "CV", "generic_name": "pregabalin", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "150 mg/1"}], "application_number": "ANDA208113", "marketing_category": "ANDA", "marketing_start_date": "20240517", "listing_expiration_date": "20261231"}