progesterone vaginal insert

Generic: progesterone

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name progesterone vaginal insert
Generic Name progesterone
Labeler xiromed, llc
Dosage Form INSERT
Routes
VAGINAL
Active Ingredients

progesterone 100 mg/1

Manufacturer
XIROMED, LLC

Identifiers & Regulatory

Product NDC 70700-201
Product ID 70700-201_5264f1f1-0a2d-1506-22f5-71074729ece9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218391
Listing Expiration 2027-12-31
Marketing Start 2025-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700201
Hyphenated Format 70700-201

Supplemental Identifiers

RxCUI
725094
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 vaginal insert (source: ndc)
Generic Name progesterone (source: ndc)
Application Number ANDA218391 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 CARTON in 1 CARTON (70700-201-70) / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68)
source: ndc

Packages (1)

70700-201-70 1 CARTON in 1 CARTON (70700-201-70) / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68)

Ingredients (1)

progesterone (100 mg/1)

Linked Drug Pages (1)

Progesterone vaginal insert ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "5264f1f1-0a2d-1506-22f5-71074729ece9", "openfda": {"nui": ["M0017672", "N0000175601"], "unii": ["4G7DS2Q64Y"], "rxcui": ["725094"], "spl_set_id": ["473ab609-5b9e-3cb8-68d5-4a459a2ea6c1"], "pharm_class_cs": ["Progesterone [CS]"], "pharm_class_epc": ["Progesterone [EPC]"], "manufacturer_name": ["XIROMED, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 CARTON (70700-201-70)  / 21 BLISTER PACK in 1 CARTON (70700-201-69)  / 1 INSERT in 1 BLISTER PACK (70700-201-68)", "package_ndc": "70700-201-70", "marketing_start_date": "20250923"}], "brand_name": "Progesterone vaginal insert", "product_id": "70700-201_5264f1f1-0a2d-1506-22f5-71074729ece9", "dosage_form": "INSERT", "pharm_class": ["Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "70700-201", "generic_name": "Progesterone", "labeler_name": "XIROMED, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Progesterone vaginal insert", "active_ingredients": [{"name": "PROGESTERONE", "strength": "100 mg/1"}], "application_number": "ANDA218391", "marketing_category": "ANDA", "marketing_start_date": "20250923", "listing_expiration_date": "20271231"}