Home NDC 51672-1303 Econazole Nitrate
Product NDC 51672-1303
11-digit product format 516721303
Labeler code 51672
Product ID 51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Econazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076005
Marketing category ANDA
Marketing start 2002-11-26
Substance ECONAZOLE NITRATE
Active strength 10 mg/g
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 A076005-001 ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076005-001 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 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076005-001 ECONAZOLE NITRATE 1% CREAM / TOPICAL AB 2002-11-26 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 Econazole Nitrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ECONAZOLE NITRATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H438WYN10E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857366 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 51672-1303-1 Econazole Nitrate 15 g in 1 TUBE CREAM 15 8 51672-1303-1 Econazole Nitrate 1 in 1 CARTON CREAM 1 8 51672-1303-2 Econazole Nitrate 30 g in 1 TUBE CREAM 30 8 51672-1303-2 Econazole Nitrate 1 in 1 CARTON CREAM 1 8 51672-1303-8 Econazole Nitrate 85 g in 1 TUBE CREAM 85 8 51672-1303-8 Econazole Nitrate 1 in 1 CARTON CREAM 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Econazole Nitrate ACTIVE INGREDIENT H438WYN10E ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Econazole ACTIVE MOIETY 6Z1Y2V4A7M ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 apricot kernel oil PEG-6 esters INACTIVE INGREDIENT DRG3KJZ1TJ ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 benzoic acid INACTIVE INGREDIENT 8SKN0B0MIM ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 butylated hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glycol stearate INACTIVE INGREDIENT 0324G66D0E ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 PEG-32 stearate INACTIVE INGREDIENT 33GX5WQC0M ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 PEG-6 stearate INACTIVE INGREDIENT 8LQC57C6B0 ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 ECONAZOLE NITRATE ACTIVE INGREDIENT H438WYN10E ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 ECONAZOLE ACTIVE MOIETY 6Z1Y2V4A7M ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 APRICOT KERNEL OIL PEG-6 ESTERS INACTIVE INGREDIENT DRG3KJZ1TJ ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 PEG-32 STEARATE INACTIVE INGREDIENT 33GX5WQC0M ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 PEG-6 STEARATE INACTIVE INGREDIENT 8LQC57C6B0 ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1303 ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 Current NDC, Legacy NDC, 6 package rows 20241222_90c40d7f-94fa-440c-9815-30378f76ae79.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 51672-1303-1 51672130301 1 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBE 1 tube 2002-11-26 0000-00-00 No No Current 51672-1303-2 51672130302 1 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBE 1 tube 2002-11-26 0000-00-00 No No Current 51672-1303-8 51672130308 1 TUBE in 1 CARTON (51672-1303-8) / 85 g in 1 TUBE 1 tube 2002-11-26 0000-00-00 No No Current