pregabalin

Generic: pregabalin

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler cadila pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 225 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-038
Product ID 71209-038_be6557c8-0d68-4313-a689-c2fdfb1d505e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206452
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-07-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209038
Hyphenated Format 71209-038

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 ANDA206452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (71209-038-04)
source: ndc

Packages (1)

71209-038-04 90 CAPSULE in 1 BOTTLE (71209-038-04)

Ingredients (1)

pregabalin (225 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": "be6557c8-0d68-4313-a689-c2fdfb1d505e", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["170c0c95-2ee8-4dff-bbd6-b87a21e8cf81"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71209-038-04)", "package_ndc": "71209-038-04", "marketing_start_date": "20230713"}], "brand_name": "PREGABALIN", "product_id": "71209-038_be6557c8-0d68-4313-a689-c2fdfb1d505e", "dosage_form": "CAPSULE", "product_ndc": "71209-038", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "225 mg/1"}], "application_number": "ANDA206452", "marketing_category": "ANDA", "marketing_start_date": "20230713", "listing_expiration_date": "20261231"}