Home NDC 11509-0426 VAGISTAT
Product NDC 11509-0426
11-digit product format 115090426
Labeler code 11509
Product ID 11509-0426_8c436269-2f52-4ddf-b3be-cec3069a8865
Type HUMAN OTC DRUG
Nonproprietary name Tioconazole
Dosage form OINTMENT
Route VAGINAL
Labeler Combe Incorporated
Application ANDA075915
Marketing category ANDA
Marketing start 2020-07-29
Substance TIOCONAZOLE
Active strength 6.5 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075915-001 TIOCONAZOLE TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21
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 · 41 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 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base VAGISTAT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIOCONAZOLE 6.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S57Y5X1117 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198380 Internal RxNorm lookup 1550534 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11509-0426-1 VAGISTAT 1 in 1 CARTON OINTMENT 1 3 11509-0426-1 VAGISTAT 1 in 1 POUCH OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11509-0426 VAGISTAT (TIOCONAZOLE) OINTMENT [COMBE INCORPORATED] 3 Current NDC, Legacy NDC, 2 package rows 20240702_da8eaa33-4195-487f-a234-472dd1036225.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 · 19 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 11509-0426-1 11509042601 1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR 1 pouch 2020-07-29 0000-00-00 No No Current