Home NDC 68071-4134 Clotrimazole and Betamethasone Dipropionate
Product NDC 68071-4134
11-digit product format 680714134
Labeler code 68071
Product ID 68071-4134_1a145449-0f8b-a78e-e063-6394a90ad576
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clotrimazole and Betamethasone Dipropionate
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA202894
Marketing category ANDA
Marketing start 2015-11-06
Substance CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
Active strength 10; .5 mg/g; mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4134-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4134-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4134-4 1332a3947898…d4bfe170f9cd…
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 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% CREAM / TOPICAL 2015-10-30
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 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL 2015-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL 2015-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL 2015-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL 2015-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202894-001 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1% CREAM / TOPICAL AB 2015-10-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 Clotrimazole and Betamethasone Dipropionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/g BETAMETHASONE DIPROPIONATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup 826Y60901U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308714 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 68071-4134-4 Clotrimazole and Betamethasone Dipropionate 45 g in 1 BOX CREAM 45 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4134 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240606_5cc511e4-3e7d-70d6-e053-2a91aa0a8044.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 · 4 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 68071-4134-4 68071413404 45 g in 1 BOX (68071-4134-4) 45 g 2017-10-30 0000-00-00 No No Current