FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
51672-2035
Requested package NDC
51672-2035-7
11-digit product format
516722035
Labeler code
51672
Product ID
51672-2035_362a2e22-e1bb-aae7-e063-6394a90a33f0
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA074444
Marketing category
ANDA
Marketing start
1997-01-13
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074444-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13

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 UTC2026-02A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
6b34d0be-4bcd-4dff-b732-7fbd46765019Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51672-2035-62020-02-03Miconazole Nitrate
51672-2035-72020-02-03Miconazole Nitrate
51672-2035-62020-01-31Miconazole Nitrate
51672-2035-72020-01-31Miconazole Nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2035-6Miconazole Nitrate45 g in 1 TUBE, WITH APPLICATORCREAM454
51672-2035-6Miconazole Nitrate1 in 1 CARTONCREAM14
51672-2035-7Miconazole Nitrate1 in 1 CARTONCREAM14
51672-2035-7Miconazole Nitrate45 g in 1 TUBE, WITH APPLICATORCREAM454

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2035-6GM - Gram51672-2035ca7f881d-7207-42aa-a3d7-8fd4ebfcb0a412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
MiconazoleACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2035MICONAZOLE NITRATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 4 package rows20250529_6b34d0be-4bcd-4dff-b732-7fbd46765019.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 NitrateMICONAZOLE NITRATEA-S Medication Solutionsa32fc37b-bcad-4f56-8dc6-cf36a67161962026-02-19WarningsExact identifier
application applno (ANDA): 074444
application number: ANDA074444
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.6b34d0be-4bcd-4dff-b732-7fbd467650192025-05-27WarningsExact identifier
application applno (ANDA): 074444
application number: ANDA074444
ndc (package): 51672-2035-7
ndc (product): 51672-2035
ndc11 (package): 51672203507
Miconazole 7MICONAZOLE NITRATETARGET Corporationedaca770-bc76-4ac2-bad2-cf8e7de0c6822025-05-27WarningsExact identifier
application applno (ANDA): 074444
application number: ANDA074444
Miconazole 7MICONAZOLE NITRATECVS Pharmacy5e7e4cf8-24ec-486e-9389-546ffea004d02025-05-27WarningsExact identifier
application applno (ANDA): 074444
application number: ANDA074444

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNa32fc37b-bcad-4f56-8dc6-cf36a67161969
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDa32fc37b-bcad-4f56-8dc6-cf36a67161969
998540miconazole nitrate 2 % Vaginal CreamSYa32fc37b-bcad-4f56-8dc6-cf36a67161969
998540miconazole nitrate 2 % Vaginal CreamPSN6b34d0be-4bcd-4dff-b732-7fbd467650194
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD6b34d0be-4bcd-4dff-b732-7fbd467650194
998540miconazole nitrate 2 % Vaginal CreamSY6b34d0be-4bcd-4dff-b732-7fbd467650194
998540miconazole nitrate 2 % Vaginal CreamPSNf562b57d-65a8-93fa-e053-2995a90ae3e01
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDf562b57d-65a8-93fa-e053-2995a90ae3e01
998540miconazole nitrate 2 % Vaginal CreamSYf562b57d-65a8-93fa-e053-2995a90ae3e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-2035-7516722035071 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR1997-01-130000-00-00NoNoCurrent