Home NDC 68462-297 Ciclopirox Olamine
Product NDC 68462-297
11-digit product format 684620297
Labeler code 68462
Product ID 68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciclopirox Olamine
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090273
Marketing category ANDA
Marketing start 2009-11-13
Substance CICLOPIROX OLAMINE
Active strength 7.7 mg/g
Pharmacologic classes Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A090273-001 CICLOPIROX CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090273-001 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 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090273-001 CICLOPIROX 0.77% CREAM / TOPICAL AB 2009-11-10 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 Ciclopirox Olamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CICLOPIROX OLAMINE 7.7 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 50MD4SB4AP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309289 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 68462-297-17 Ciclopirox Olamine 15 g in 1 CARTON CREAM 15 12 68462-297-35 Ciclopirox Olamine 30 g in 1 CARTON CREAM 30 12 68462-297-92 Ciclopirox Olamine 90 g in 1 CARTON CREAM 90 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CICLOPIROX OLAMINE ACTIVE INGREDIENT 50MD4SB4AP CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 CICLOPIROX ACTIVE MOIETY 19W019ZDRJ CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 MYRISTYL ALCOHOL INACTIVE INGREDIENT V42034O9PU CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 WATER INACTIVE INGREDIENT 059QF0KO0R CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 8 CICLOPIROX OLAMINE ACTIVE INGREDIENT 50MD4SB4AP CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 CICLOPIROX ACTIVE MOIETY 19W019ZDRJ CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 MYRISTYL ALCOHOL INACTIVE INGREDIENT V42034O9PU CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-297 CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 11 Current NDC, Legacy NDC, 3 package rows 20240104_7385cf42-9f80-4542-8e0f-a0228aa9b43a.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 68462-297-17 68462029717 15 g in 1 CARTON (68462-297-17) 15 g 2009-11-13 0000-00-00 No No Current 68462-297-35 68462029735 30 g in 1 CARTON (68462-297-35) 30 g 2009-11-13 0000-00-00 No No Current 68462-297-92 68462029792 90 g in 1 CARTON (68462-297-92) 90 g 2009-11-13 0000-00-00 No No Current