Home NDC 68462-711-88 ESTRADIOL VAGINAL INSERTS
Product NDC 68462-711
Requested package NDC 68462-711-88
11-digit product format 684620711
Labeler code 68462
Product ID 68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form TABLET, FILM COATED
Route VAGINAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA210264
Marketing category ANDA
Marketing start 2018-09-17
Substance ESTRADIOL
Active strength 10 ug/1
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210264-001 ESTRADIOL ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210264-001 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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210264-001 ESTRADIOL 10MCG TABLET / VAGINAL AB 2018-09-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 ESTRADIOL VAGINAL INSERTS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL 10 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4TI98Z838E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884707 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 68462-711-71 ESTRADIOL VAGINAL INSERTS 8 in 1 CARTON TABLET, FILM COATED 8 7 68462-711-71 ESTRADIOL VAGINAL INSERTS 1 in 1 APPLICATOR TABLET, FILM COATED 1 7 68462-711-88 ESTRADIOL VAGINAL INSERTS 18 in 1 CARTON TABLET, FILM COATED 18 7 68462-711-88 ESTRADIOL VAGINAL INSERTS 1 in 1 APPLICATOR TABLET, FILM COATED 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-711 ESTRADIOL VAGINAL INSERTS (ESTRADIOL) TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 Current NDC, Legacy NDC, 4 package rows 20240313_86620f6c-fd02-40df-98d5-3048dcd92c37.zip
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 Marketing end Sample Exclude flag Status 68462-711-88 68462071188 18 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATOR 18 applicator 2018-09-17 0000-00-00 No No Current