Home NDC 68071-1626-2 Terconazole
Product NDC 68071-1626
Requested package NDC 68071-1626-2
11-digit product format 680711626
Labeler code 68071
Product ID 68071-1626_2a0a39a9-3e19-1ddb-e063-6394a90a9d78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terconazole
Dosage form CREAM
Route VAGINAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA075953
Marketing category ANDA
Marketing start 2004-04-06
Substance TERCONAZOLE
Active strength 8 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A075953-001 TERCONAZOLE TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075953-001 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 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075953-001 TERCONAZOLE 0.8% CREAM / VAGINAL BX RS 2004-04-06 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-1626-2 Terconazole 20 g in 1 BOX CREAM 20 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-1626 TERCONAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241226_71c13149-396e-edc6-e053-2a95a90af50c.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 · 3 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 68071-1626-2 68071162602 20 g in 1 BOX (68071-1626-2) 20 g 2018-07-24 0000-00-00 No No Current