Home NDC 0169-5176 Vagifem
Product NDC 0169-5176
11-digit product format 001695176
Labeler code 0169
Product ID 0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form INSERT
Route VAGINAL
Labeler Novo Nordisk
Application NDA020908
Marketing category NDA
Marketing start 2010-01-11
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020908-001 VAGIFEM ESTRADIOL 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 N020908-002 VAGIFEM ESTRADIOL 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020908-002 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020908-001 VAGIFEM 25MCG TABLET / VAGINAL RLD 1999-03-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020908-001 VAGIFEM 25MCG TABLET / VAGINAL RLD 1999-03-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / VAGINAL RLD 1999-03-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / VAGINAL RLD 1999-03-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020908-001 VAGIFEM 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / VAGINAL RLD 1999-03-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020908-002 VAGIFEM 10MCG TABLET / VAGINAL AB RLD, RS 2009-11-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Additional Listing Data#
Finished product Yes
Brand name base Vagifem
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884707 Internal RxNorm lookup 884709 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTRADIOL ACTIVE INGREDIENT 4TI98Z838E VAGIFEM (ESTRADIOL) TABLET, FILM COATED [NOVO NORDISK] 10 ESTRADIOL ACTIVE MOIETY 4TI98Z838E VAGIFEM (ESTRADIOL) TABLET, FILM COATED [NOVO NORDISK] 10 ESTRADIOL ACTIVE INGREDIENT 4TI98Z838E VAGIFEM (ESTRADIOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 ESTRADIOL ACTIVE MOIETY 4TI98Z838E VAGIFEM (ESTRADIOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VAGIFEM (ESTRADIOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-5176 VAGIFEM (ESTRADIOL) INSERT [NOVO NORDISK] 22 Current NDC, Legacy NDC, 6 package rows 20250212_e5ad3cf6-dd96-4e64-af21-c1eee38d0b88.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 0169-5176-03 00169517603 8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR 8 applicator 2010-01-11 0000-00-00 No No Current 0169-5176-04 00169517604 18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR 18 applicator 2010-01-11 0000-00-00 No No Current 0169-5176-99 00169517699 6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR 6 applicator 2010-01-11 0000-00-00 No No Current