pregabalin

Generic: pregabalin

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

Drug Facts

Product Profile

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

pregabalin 225 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-364
Product ID 13668-364_57dc1c67-2d03-4ba9-9730-34ef1e80d24e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206942
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-05-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668364
Hyphenated Format 13668-364

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0313668361308 0313668365306 0313668358308 0313668359305 0313668364309 0313668362305
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 ANDA206942 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (13668-364-01)
  • 500 CAPSULE in 1 BOTTLE (13668-364-05)
  • 30 CAPSULE in 1 BOTTLE (13668-364-30)
  • 60 CAPSULE in 1 BOTTLE (13668-364-60)
source: ndc

Packages (4)

13668-364-01 100 CAPSULE in 1 BOTTLE (13668-364-01) 13668-364-05 500 CAPSULE in 1 BOTTLE (13668-364-05) 13668-364-30 30 CAPSULE in 1 BOTTLE (13668-364-30) 13668-364-60 60 CAPSULE in 1 BOTTLE (13668-364-60)

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": "57dc1c67-2d03-4ba9-9730-34ef1e80d24e", "openfda": {"upc": ["0313668361308", "0313668365306", "0313668358308", "0313668359305", "0313668364309", "0313668362305"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["a062e78a-16ff-4d83-b700-0badb7d812d5"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (13668-364-01)", "package_ndc": "13668-364-01", "marketing_start_date": "20250519"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (13668-364-05)", "package_ndc": "13668-364-05", "marketing_start_date": "20250519"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (13668-364-30)", "package_ndc": "13668-364-30", "marketing_start_date": "20250519"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (13668-364-60)", "package_ndc": "13668-364-60", "marketing_start_date": "20250519"}], "brand_name": "Pregabalin", "product_id": "13668-364_57dc1c67-2d03-4ba9-9730-34ef1e80d24e", "dosage_form": "CAPSULE", "product_ndc": "13668-364", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "225 mg/1"}], "application_number": "ANDA206942", "marketing_category": "ANDA", "marketing_start_date": "20250519", "listing_expiration_date": "20261231"}