FDA.reportPublic FDA data

MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit

Product NDC
0713-0593
11-digit product format
007130593
Labeler code
0713
Product ID
0713-0593_2b1109b2-d1c4-6d16-e063-6394a90a5df5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA074926
Marketing category
ANDA
Marketing start
2025-01-03
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074926-001M-ZOLE 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992765Internal RxNorm lookup
992766Internal RxNorm lookup
998483Internal RxNorm lookup
998540Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eed88487-a7ba-4853-8519-13f92ed5539fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0593-77MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0593-77EA - Each0713-059368ee4744-c012-4920-ab23-b3d35d8cde8012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0593MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT (MICONAZOLE NITRATE) KIT [COSETTE PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20250108_eed88487-a7ba-4853-8519-13f92ed5539f.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3 Combination PackMICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc2025-09-08WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
Miconazole 3 Combination PackMICONAZOLE NITRATEChain Drug Consortium, LLCd01f7ef9-4f04-4874-a625-0335f6392b732025-09-05WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitMICONAZOLE NITRATECosette Pharmaceuticals, Inc.eed88487-a7ba-4853-8519-13f92ed5539f2025-01-06WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
ndc (product): 0713-0593
Miconazole 3 Combination PackMICONAZOLE NITRATECVS Pharmacy65c99592-7c11-41fc-8296-aad0a8f399262023-01-18WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKeed88487-a7ba-4853-8519-13f92ed5539f2
998483miconazole nitrate 2 % Topical CreamPSNeed88487-a7ba-4853-8519-13f92ed5539f2
998540miconazole nitrate 2 % Vaginal CreamPSNeed88487-a7ba-4853-8519-13f92ed5539f2
992765miconazole nitrate 200 MG Vaginal InsertPSNeed88487-a7ba-4853-8519-13f92ed5539f2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNeed88487-a7ba-4853-8519-13f92ed5539f2
998483miconazole nitrate 20 MG/ML Topical CreamSCDeed88487-a7ba-4853-8519-13f92ed5539f2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDeed88487-a7ba-4853-8519-13f92ed5539f2
992765miconazole nitrate 200 MG Vaginal InsertSCDeed88487-a7ba-4853-8519-13f92ed5539f2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYeed88487-a7ba-4853-8519-13f92ed5539f2
992766miconazole 3 Day Vaginal Insert Combination PackSYeed88487-a7ba-4853-8519-13f92ed5539f2
998483miconazole nitrate 2 % Topical CreamSYeed88487-a7ba-4853-8519-13f92ed5539f2
998540miconazole nitrate 2 % Vaginal CreamSYeed88487-a7ba-4853-8519-13f92ed5539f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0713-0593-77007130593771 KIT in 1 CARTON (0713-0593-77) * 9 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit2025-01-03NoNoCurrent