progesterone

Generic: progesterone

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

Drug Facts

Product Profile

Brand Name progesterone
Generic Name progesterone
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

progesterone 100 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-582
Product ID 76420-582_3485f152-22bd-e5bd-e063-6394a90afa5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200900
Listing Expiration 2026-12-31
Marketing Start 2018-11-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420582
Hyphenated Format 76420-582

Supplemental Identifiers

RxCUI
260243 312641
UNII
4G7DS2Q64Y
NUI
M0017672 N0000175601

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 ANDA200900 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-582-10)
  • 30 CAPSULE in 1 BOTTLE (76420-582-30)
  • 60 CAPSULE in 1 BOTTLE (76420-582-60)
  • 90 CAPSULE in 1 BOTTLE (76420-582-90)
source: ndc

Packages (4)

76420-582-10 100 CAPSULE in 1 BOTTLE (76420-582-10) 76420-582-30 30 CAPSULE in 1 BOTTLE (76420-582-30) 76420-582-60 60 CAPSULE in 1 BOTTLE (76420-582-60) 76420-582-90 90 CAPSULE in 1 BOTTLE (76420-582-90)

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": "3485f152-22bd-e5bd-e063-6394a90afa5b", "openfda": {"nui": ["M0017672", "N0000175601"], "unii": ["4G7DS2Q64Y"], "rxcui": ["260243", "312641"], "spl_set_id": ["342a096d-df6f-47de-bdd1-ec259638e476"], "pharm_class_cs": ["Progesterone [CS]"], "pharm_class_epc": ["Progesterone [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-582-10)", "package_ndc": "76420-582-10", "marketing_start_date": "20230818"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-582-30)", "package_ndc": "76420-582-30", "marketing_start_date": "20230818"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-582-60)", "package_ndc": "76420-582-60", "marketing_start_date": "20230818"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-582-90)", "package_ndc": "76420-582-90", "marketing_start_date": "20230818"}], "brand_name": "PROGESTERONE", "product_id": "76420-582_3485f152-22bd-e5bd-e063-6394a90afa5b", "dosage_form": "CAPSULE", "pharm_class": ["Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "76420-582", "generic_name": "PROGESTERONE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROGESTERONE", "active_ingredients": [{"name": "PROGESTERONE", "strength": "100 mg/1"}], "application_number": "ANDA200900", "marketing_category": "ANDA", "marketing_start_date": "20181128", "listing_expiration_date": "20261231"}