Home NDC 51672-1304 Terconazole
Product NDC 51672-1304
11-digit product format 516721304
Labeler code 51672
Product ID 51672-1304_362a84ff-741f-ed45-e063-6394a90a54e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terconazole
Dosage form CREAM
Route VAGINAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076043
Marketing category ANDA
Marketing start 2005-01-19
Substance TERCONAZOLE
Active strength 4 mg/g
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 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 A076043-001 TERCONAZOLE TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076043-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076043-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB RS 2005-01-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Terconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERCONAZOLE 4 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0KJ2VE664U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313226 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 51672-1304-6 Terconazole 1 in 1 CARTON CREAM 1 10 51672-1304-6 Terconazole 45 g in 1 TUBE, WITH APPLICATOR CREAM 45 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Terconazole ACTIVE INGREDIENT 0KJ2VE664U TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 Terconazole ACTIVE MOIETY 0KJ2VE664U TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 Terconazole ACTIVE INGREDIENT 0KJ2VE664U TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 Terconazole ACTIVE MOIETY 0KJ2VE664U TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1 water INACTIVE INGREDIENT 059QF0KO0R TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1304 TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241222_2b3923b5-0a97-428c-b8d2-4a3ceb3447a1.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51672-1304-6 51672130406 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6) / 45 g in 1 TUBE, WITH APPLICATOR 2005-01-19 0000-00-00 No No Current