Home NDC 63629-8837 Terconazole
Product NDC 63629-8837
11-digit product format 636298837
Labeler code 63629
Product ID 63629-8837_0b09e1bf-e3d4-4bae-8a70-d3451f4323a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name terconazole
Dosage form CREAM
Route VAGINAL
Labeler Bryant Ranch Prepack
Application NDA021735
Marketing category NDA
Marketing start 2005-02-01
Marketing end 0000-00-00
Substance TERCONAZOLE
Active strength 8 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8837 TERCONAZOLE VAGINAL CREAM 0.8% (TERCONAZOLE) CREAM [BRYANT RANCH PREPACK] 102 Legacy NDC 20240116_2de0f965-fba6-43a3-a3d8-9740349df6a7.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8837-1 63629883701 20 g in 1 TUBE, WITH APPLICATOR (63629-8837-1) 20 g 2021-09-10 0000-00-00 No No Current