Home NDC 50742-359 Progesterone
Product NDC 50742-359
11-digit product format 507420359
Labeler code 50742
Product ID 50742-359_2b7a32c4-b3ab-46e3-b3c7-bbb2553b8b3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form INSERT
Route VAGINAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA219588
Marketing category ANDA
Marketing start 2026-10-16
Substance PROGESTERONE
Active strength 100 mg/1
Pharmacologic classes Progesterone [CS], Progesterone [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219588-001 PROGESTERONE PROGESTERONE 100MG INSERT / VAGINAL AB 2026-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219588-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-11-14 07:37:17 2026-10 A219588-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2026-10-16 d4dbc9d85df4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-11-14 07:37:17 2026-10 A219588-001 AB 1 d4dbc9d85df4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Progesterone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROGESTERONE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4G7DS2Q64Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 725094 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50742-359-21 50742035921 1 CARTON in 1 CARTON (50742-359-21) / 21 BLISTER PACK in 1 CARTON (50742-359-07) / 1 INSERT in 1 BLISTER PACK (50742-359-03) 1 carton 2026-10-16 No No Current