Home NDC 0168-0347 Terconazole
Product NDC 0168-0347
11-digit product format 001680347
Labeler code 0168
Product ID 0168-0347_4b5df750-9341-4786-8e10-b0d6950f37ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name terconazole
Dosage form CREAM
Route VAGINAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application NDA021735
Marketing category NDA
Marketing start 2005-02-01
Substance TERCONAZOLE
Active strength 8 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 N021735-001 TERCONAZOLE TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021735-001 BX
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 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021735-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RLD, RS 2004-10-01 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
Brand name suffix Vaginal Cream 0.8%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERCONAZOLE 8 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 313227 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 0168-0347-20 TerconazoleVaginal Cream 0.8% 20 g in 1 TUBE, WITH APPLICATOR CREAM 20 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0347 TERCONAZOLE VAGINAL CREAM 0.8% (TERCONAZOLE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250328_f59448bd-f730-46d2-a785-c2d6205579ff.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 0168-0347-20 00168034720 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20) 20 g 2020-12-01 0000-00-00 No No Current