FDA.reportPublic FDA data

Miconazole 3 Combination Pack

Product NDC
68016-731
11-digit product format
680160731
Labeler code
68016
Product ID
68016-731_0c7a9e1a-ac2f-4faa-afbf-b2d19287b897
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Chain Drug Consortium, LLC
Application
ANDA074926
Marketing category
ANDA
Marketing start
2003-09-11
Marketing end
2026-12-31
NDC exclude flag
No
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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992765Internal RxNorm lookup
992766Internal 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
d01f7ef9-4f04-4874-a625-0335f6392b73Available 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
68016-731-04Miconazole 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-731-04EA - Each68016-73137e52d7f-d9d3-425f-aa74-7faa7210a75d12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-731MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]13Current NDC, Legacy NDC, 1 package rows20221122_d01f7ef9-4f04-4874-a625-0335f6392b73.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
ndc (product): 68016-731
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
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) } PackGPCKd01f7ef9-4f04-4874-a625-0335f6392b7315
998540miconazole nitrate 2 % Vaginal CreamPSNd01f7ef9-4f04-4874-a625-0335f6392b7315
992765miconazole nitrate 200 MG Vaginal InsertPSNd01f7ef9-4f04-4874-a625-0335f6392b7315
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNd01f7ef9-4f04-4874-a625-0335f6392b7315
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDd01f7ef9-4f04-4874-a625-0335f6392b7315
992765miconazole nitrate 200 MG Vaginal InsertSCDd01f7ef9-4f04-4874-a625-0335f6392b7315
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYd01f7ef9-4f04-4874-a625-0335f6392b7315
992766miconazole 3 Day Vaginal Insert Combination PackSYd01f7ef9-4f04-4874-a625-0335f6392b7315
998540miconazole nitrate 2 % Vaginal CreamSYd01f7ef9-4f04-4874-a625-0335f6392b7315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-731-04680160731041 KIT in 1 PACKAGE, COMBINATION (68016-731-04) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit2003-09-112026-12-31NoNoCurrent