Home NDC 70700-201 Progesterone vaginal insert
Product NDC 70700-201
11-digit product format 707000201
Labeler code 70700
Product ID 70700-201_5264f1f1-0a2d-1506-22f5-71074729ece9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form INSERT
Route VAGINAL
Labeler XIROMED, LLC
Application ANDA218391
Marketing category ANDA
Marketing start 2025-09-23
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 A218391-001 PROGESTERONE PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218391-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A218391-001 CGT 2026-03-22
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 A218391-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218391-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218391-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218391-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19 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 A218391-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218391-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218391-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218391-001 AB 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A218391-001 CGT 2026-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218391-001 CGT 2026-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218391-001 CGT 2026-03-22 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218391-001 CGT 2026-03-22 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Progesterone vaginal insert
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 70700-201-68 Progesterone vaginal insert 1 in 1 BLISTER PACK INSERT 1 4 70700-201-69 Progesterone vaginal insert 21 in 1 CARTON INSERT 21 4 70700-201-70 Progesterone vaginal insert 1 in 1 CARTON INSERT 1 4
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 70700-201-68 70700020168 1 in 1 BLISTER PACK Historical 70700-201-69 70700020169 21 in 1 CARTON Historical 70700-201-70 70700020170 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) 1 carton 2025-09-23 No No Current