Home NDC 66993-898 Clotrimazole and Betamethasone Dipropionate
Product NDC 66993-898
11-digit product format 669930898
Labeler code 66993
Product ID 66993-898_61b9d6ae-868c-48ec-9b75-ba16adcaefb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE
Dosage form CREAM
Route TOPICAL
Labeler Prasco Laboratories
Application NDA018827
Marketing category NDA
Marketing start 1984-07-10
Marketing end 0000-00-00
Substance CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
Active strength 10 mg/g; mg/g
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 N018827-001 LOTRISONE BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10
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 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018827-001 LOTRISONE EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL RLD 1984-07-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018827-001 LOTRISONE EQ 0.05% BASE;1% CREAM / TOPICAL AB RLD, RS 1984-07-10 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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 66993-898-15 66993089815 1 TUBE in 1 BOX (66993-898-15) > 15 g in 1 TUBE 1 tube 1984-07-10 0000-00-00 No No Current 66993-898-45 66993089845 1 TUBE in 1 BOX (66993-898-45) > 45 g in 1 TUBE 1 tube 1984-07-10 0000-00-00 No No Current