Home NDC 0168-0346 Terconazole
Product NDC 0168-0346
11-digit product format 001680346
Labeler code 0168
Product ID 0168-0346_c54c82fd-d8e5-4943-8727-1432bccac7c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name terconazole
Dosage form CREAM
Route VAGINAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application ANDA076712
Marketing category ANDA
Marketing start 2005-02-18
Substance TERCONAZOLE
Active strength 4 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
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 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 A076712-001 TERCONAZOLE TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076712-001 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 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076712-001 TERCONAZOLE 0.4% CREAM / VAGINAL AB 2005-02-18 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 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0346-46 Terconazole 45 g in 1 TUBE, WITH APPLICATOR CREAM 45 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TERCONAZOLE ACTIVE INGREDIENT 0KJ2VE664U TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 TERCONAZOLE ACTIVE MOIETY 0KJ2VE664U TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 TERCONAZOLE ACTIVE INGREDIENT 0KJ2VE664U TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 TERCONAZOLE ACTIVE MOIETY 0KJ2VE664U TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0346 TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20210313_10e84353-93d2-461d-8b79-e9294df047ae.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 Units Marketing start Marketing end Sample Exclude flag Status 0168-0346-46 00168034646 45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46) 45 g 2005-02-18 0000-00-00 No No Current