Home NDC 70700-201-70 Progesterone vaginal insert
Product NDC 70700-201
Requested package NDC 70700-201-70
11-digit product format 707000201
Labeler code 70700
Product ID 70700-201_30947aaa-8093-2fb1-65a6-fed969c7bed9
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 44 .
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 2026-10-15 13:18:30 2026-09 A218391-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218391-001 PROGESTERONE 100MG INSERT / VAGINAL AB 2025-09-19 84e616aacf4f…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# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 A218391-001 CGT 2026-03-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218391-001 CGT 2026-03-22 84e616aacf4f…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…
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 vaginal insert
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROGESTERONE 100 mg/1
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70700-201-70 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