Home NDC 0713-0552 Terconazole
Product NDC 0713-0552
11-digit product format 007130552
Labeler code 0713
Product ID 0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terconazole
Dosage form SUPPOSITORY
Route VAGINAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077553
Marketing category ANDA
Marketing start 2015-09-25
Substance TERCONAZOLE
Active strength 80 mg/1
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 A077553-001 TERCONAZOLE TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077553-001 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 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077553-001 TERCONAZOLE 80MG SUPPOSITORY / VAGINAL AB 2007-03-09 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 80 mg/1
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 198245 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 0713-0552-73 Terconazole 3 in 1 CARTON SUPPOSITORY 3 3 0713-0552-73 Terconazole 1 in 1 BLISTER PACK SUPPOSITORY 1 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0552 TERCONAZOLE SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20221124_38cd1718-6b3c-415d-a17f-7b399adb0ba2.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 0713-0552-73 00713055273 3 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACK 3 blister pack 2015-09-25 0000-00-00 No No Current