Home NDC 45802-396 gynazole 1
Product NDC 45802-396
11-digit product format 458020396
Labeler code 45802
Product ID 45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butoconazole nitrate
Dosage form CREAM
Route VAGINAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA200923
Marketing category ANDA
Marketing start 2015-04-29
Substance BUTOCONAZOLE NITRATE
Active strength 100 mg/5g
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 43 .
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 A200923-001 GYNAZOLE-1 BUTOCONAZOLE NITRATE 2% CREAM / VAGINAL RS 2012-05-18
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 · 43 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 2026-09-14 22:38:34 2026-08 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200923-001 GYNAZOLE-1 2% CREAM / VAGINAL RS 2012-05-18 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base gynazole 1
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTOCONAZOLE NITRATE 100 mg/5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4805237NP5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 890785 Internal RxNorm lookup 890786 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 45802-396-01 gynazole 1 5.8 g in 1 TUBE, WITH APPLICATOR CREAM 5.8 6 45802-396-01 gynazole 1 1 in 1 CARTON CREAM 1 6 45802-396-02 gynazole 1 5.8 g in 1 TUBE, WITH APPLICATOR CREAM 5.8 6 45802-396-02 gynazole 1 1 in 1 CARTON CREAM 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-396 GYNAZOLE 1 (BUTOCONAZOLE NITRATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 6 Current NDC, Legacy NDC, 4 package rows 20230603_125d8ede-db38-4eb9-a6be-19208687f36a.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45802-396-01 45802039601 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR 2015-04-29 0000-00-00 No No Current 45802-396-02 45802039602 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR 2015-04-29 0000-00-00 Yes No Current