pregabalin

Generic: pregabalin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-413
Product ID 64980-413_ed8357e8-6f9d-4b09-b3f0-48417fe7f481
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210432
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 64980413
Hyphenated Format 64980-413

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0364980413107 0364980411103 0364980415101 0364980412100 0364980416108 0364980414104 0364980410106 0364980417105
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 ANDA210432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (64980-413-01) / 10 CAPSULE in 1 BLISTER PACK
  • 90 CAPSULE in 1 CARTON (64980-413-09)
  • 1000 CAPSULE in 1 CARTON (64980-413-10)
source: ndc

Packages (3)

64980-413-01 10 BLISTER PACK in 1 CARTON (64980-413-01) / 10 CAPSULE in 1 BLISTER PACK 64980-413-09 90 CAPSULE in 1 CARTON (64980-413-09) 64980-413-10 1000 CAPSULE in 1 CARTON (64980-413-10)

Ingredients (1)

pregabalin (100 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": "ed8357e8-6f9d-4b09-b3f0-48417fe7f481", "openfda": {"upc": ["0364980413107", "0364980411103", "0364980415101", "0364980412100", "0364980416108", "0364980414104", "0364980410106", "0364980417105"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["dbebfa61-0685-41b4-8364-00b8d8b73714"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (64980-413-01)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "64980-413-01", "marketing_start_date": "20190719"}, {"sample": false, "description": "90 CAPSULE in 1 CARTON (64980-413-09)", "package_ndc": "64980-413-09", "marketing_start_date": "20190719"}, {"sample": false, "description": "1000 CAPSULE in 1 CARTON (64980-413-10)", "package_ndc": "64980-413-10", "marketing_start_date": "20190719"}], "brand_name": "PREGABALIN", "product_id": "64980-413_ed8357e8-6f9d-4b09-b3f0-48417fe7f481", "dosage_form": "CAPSULE", "product_ndc": "64980-413", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA210432", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}