prometrium

Generic: progesterone

Labeler: acertis pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prometrium
Generic Name progesterone
Labeler acertis pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

progesterone 100 mg/1

Manufacturer
Acertis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 72989-372
Product ID 72989-372_3d2fed08-88a5-4645-b158-33527a2556eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019781
Listing Expiration 2027-12-31
Marketing Start 2022-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72989372
Hyphenated Format 72989-372

Supplemental Identifiers

RxCUI
260243 261319 262080 312641
UPC
0372989372301 0372989373308
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 prometrium (source: ndc)
Generic Name progesterone (source: ndc)
Application Number NDA019781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72989-372-30)
source: ndc

Packages (1)

72989-372-30 30 CAPSULE in 1 BOTTLE (72989-372-30)

Ingredients (1)

progesterone (100 mg/1)

Linked Drug Pages (1)

Prometrium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d2fed08-88a5-4645-b158-33527a2556eb", "openfda": {"nui": ["M0017672", "N0000175601"], "upc": ["0372989372301", "0372989373308"], "unii": ["4G7DS2Q64Y"], "rxcui": ["260243", "261319", "262080", "312641"], "spl_set_id": ["1cf237ff-c4f8-4faa-a7aa-77599c856889"], "pharm_class_cs": ["Progesterone [CS]"], "pharm_class_epc": ["Progesterone [EPC]"], "manufacturer_name": ["Acertis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72989-372-30)", "package_ndc": "72989-372-30", "marketing_start_date": "20221101"}], "brand_name": "Prometrium", "product_id": "72989-372_3d2fed08-88a5-4645-b158-33527a2556eb", "dosage_form": "CAPSULE", "pharm_class": ["Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "72989-372", "generic_name": "Progesterone", "labeler_name": "Acertis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prometrium", "active_ingredients": [{"name": "PROGESTERONE", "strength": "100 mg/1"}], "application_number": "NDA019781", "marketing_category": "NDA", "marketing_start_date": "20221101", "listing_expiration_date": "20271231"}