pregabalin

Generic: pregabalin

Labeler: cipla usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler cipla usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 50 mg/1

Manufacturer
Cipla USA, Inc.

Identifiers & Regulatory

Product NDC 69097-955
Product ID 69097-955_96d9d734-42e6-474d-a75e-0381de0a8ec1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211384
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097955
Hyphenated Format 69097-955

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0369097955052 0369097957056 0369097956059 0369097958053 0369097954055 0369097962050 0369097961053
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 ANDA211384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (69097-955-05)
  • 500 CAPSULE in 1 BOTTLE (69097-955-12)
source: ndc

Packages (2)

69097-955-05 90 CAPSULE in 1 BOTTLE (69097-955-05) 69097-955-12 500 CAPSULE in 1 BOTTLE (69097-955-12)

Ingredients (1)

pregabalin (50 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": "96d9d734-42e6-474d-a75e-0381de0a8ec1", "openfda": {"upc": ["0369097955052", "0369097957056", "0369097956059", "0369097958053", "0369097954055", "0369097962050", "0369097961053"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["17a8087c-579f-42de-ae92-006ea64def2a"], "manufacturer_name": ["Cipla USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (69097-955-05)", "package_ndc": "69097-955-05", "marketing_start_date": "20190719"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (69097-955-12)", "package_ndc": "69097-955-12", "marketing_start_date": "20190719"}], "brand_name": "Pregabalin", "product_id": "69097-955_96d9d734-42e6-474d-a75e-0381de0a8ec1", "dosage_form": "CAPSULE", "product_ndc": "69097-955", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Cipla USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "50 mg/1"}], "application_number": "ANDA211384", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}