Home NDC 68462-175 PROGESTERONE VAGINAL INSERTS
Product NDC 68462-175
11-digit product format 684620175
Labeler code 68462
Product ID 68462-175_41682665-e889-4e2a-9382-88f6bcc30237
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name progesterone
Dosage form INSERT
Route VAGINAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA216363
Marketing category ANDA
Marketing start 2026-04-08
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 42 .
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 A216363-001 PROGESTERONE PROGESTERONE 100MG INSERT / VAGINAL AB 2026-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216363-001 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 2026-08-18 06:07:40 2026-07 A216363-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2026-04-08 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216363-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2026-04-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A216363-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216363-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base PROGESTERONE VAGINAL INSERTS
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-175-33 PROGESTERONE VAGINAL INSERTS 21 in 1 CARTON INSERT 21 1 68462-175-40 PROGESTERONE VAGINAL INSERTS 1 in 1 BLISTER PACK INSERT 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68462-175-33 68462017533 21 BLISTER PACK in 1 CARTON (68462-175-33) / 1 INSERT in 1 BLISTER PACK (68462-175-40) 21 blister pack 2026-04-08 No No Current 68462-175-40 68462017540 1 in 1 BLISTER PACK Historical