progesterone

Generic: progesterone

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name progesterone
Generic Name progesterone
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

progesterone 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-261
Product ID 63323-261_e03e68a3-f9df-4c3f-bd1f-30fae68433f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075906
Listing Expiration 2026-12-31
Marketing Start 2001-07-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323261
Hyphenated Format 63323-261

Supplemental Identifiers

RxCUI
312644
UPC
0363323261108
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 ANDA075906 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

63323-261-10 1 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

progesterone (50 mg/mL)

Linked Drug Pages (1)

Progesterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "e03e68a3-f9df-4c3f-bd1f-30fae68433f3", "openfda": {"nui": ["M0017672", "N0000175601"], "upc": ["0363323261108"], "unii": ["4G7DS2Q64Y"], "rxcui": ["312644"], "spl_set_id": ["a479b395-1e1a-4d2a-8feb-68a15c47225f"], "pharm_class_cs": ["Progesterone [CS]"], "pharm_class_epc": ["Progesterone [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-261-10", "marketing_start_date": "20010719"}], "brand_name": "Progesterone", "product_id": "63323-261_e03e68a3-f9df-4c3f-bd1f-30fae68433f3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "63323-261", "generic_name": "PROGESTERONE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Progesterone", "active_ingredients": [{"name": "PROGESTERONE", "strength": "50 mg/mL"}], "application_number": "ANDA075906", "marketing_category": "ANDA", "marketing_start_date": "20010719", "listing_expiration_date": "20261231"}