Home NDC 0574-0107 Clotrimazole
Product NDC 0574-0107
11-digit product format 005740107
Labeler code 0574
Product ID 0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clotrimazole
Dosage form LOZENGE
Route ORAL
Labeler Padagis US LLC
Application ANDA076763
Marketing category ANDA
Marketing start 2005-12-01
Substance CLOTRIMAZOLE
Active strength 10 mg/1
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 1 .
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 A076763-001 CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076763-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076763-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB 2005-10-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clotrimazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309371 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 0574-0107-14 Clotrimazole 140 in 1 BOTTLE, PLASTIC LOZENGE 140 6 0574-0107-70 Clotrimazole 70 in 1 BOTTLE, PLASTIC LOZENGE 70 6 0574-0107-77 Clotrimazole 1 in 1 PACKET LOZENGE 1 6 0574-0107-77 Clotrimazole 70 in 1 BOX LOZENGE 70 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] 3 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] 3 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] 3 CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] 2 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] 2 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0107 CLOTRIMAZOLE LOZENGE [PADAGIS US LLC] 6 Current NDC, Legacy NDC, 4 package rows 20231202_3f57ef51-8202-4d0b-95a8-d2df468b8d9a.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 Units Marketing start Marketing end Sample Exclude flag Status 0574-0107-14 00574010714 140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14) 140 lozenge 2005-12-01 0000-00-00 No No Current 0574-0107-70 00574010770 70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70) 70 lozenge 2005-12-01 0000-00-00 No No Current 0574-0107-77 00574010777 70 PACKET in 1 BOX (0574-0107-77) / 1 LOZENGE in 1 PACKET 70 packet 2005-12-01 0000-00-00 No No Current