progesterone

Generic: progesterone

Labeler: hikma pharmaceuticals usa inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name progesterone
Generic Name progesterone
Labeler hikma pharmaceuticals usa inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

progesterone 100 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc

Identifiers & Regulatory

Product NDC 0054-0829
Product ID 0054-0829_6b088496-3f4c-4090-8185-0d04b028096b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200456
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

Pharmacologic Class

Established (EPC)
progesterone [epc]
Chemical Structure
progesterone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540829
Hyphenated Format 0054-0829

Supplemental Identifiers

RxCUI
260243 312641
UNII
4G7DS2Q64Y
NUI
M0017672 N0000175601

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 progesterone (source: ndc)
Generic Name progesterone (source: ndc)
Application Number ANDA200456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0054-0829-25)
source: ndc

Packages (1)

0054-0829-25 100 CAPSULE in 1 BOTTLE (0054-0829-25)

Ingredients (1)

progesterone (100 mg/1)

Linked Drug Pages (1)

Progesterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b088496-3f4c-4090-8185-0d04b028096b", "openfda": {"nui": ["M0017672", "N0000175601"], "unii": ["4G7DS2Q64Y"], "rxcui": ["260243", "312641"], "spl_set_id": ["d8bcc439-c21d-4eeb-9159-f51e0c60bd70"], "pharm_class_cs": ["Progesterone [CS]"], "pharm_class_epc": ["Progesterone [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0054-0829-25)", "package_ndc": "0054-0829-25", "marketing_start_date": "20250515"}], "brand_name": "Progesterone", "product_id": "0054-0829_6b088496-3f4c-4090-8185-0d04b028096b", "dosage_form": "CAPSULE", "pharm_class": ["Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "0054-0829", "generic_name": "Progesterone", "labeler_name": "Hikma Pharmaceuticals USA Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Progesterone", "active_ingredients": [{"name": "PROGESTERONE", "strength": "100 mg/1"}], "application_number": "ANDA200456", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}