FDA.reportPublic FDA data

Vagistat-3

Product NDC
76413-352
11-digit product format
764130352
Labeler code
76413
Product ID
76413-352_939ce2ff-51df-4785-a7aa-5291916e59e6
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Central Texas Community Health Centers
Application
ANDA075329
Marketing category
ANDA
Marketing start
2000-02-25
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-352IInactivated by FDA2026-08-03
excluded packagepackage76413-35276413-352-03IInactivated by FDA2026-08-03

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
A075329-001MICONAZOLE NITRATE COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-10-29 15:01 UTC2024-10A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-203f01610625f2…
2019-09-15 20:21 UTC2019-09A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20cb3db0bc1861…
2026-08-01 22:54:322026-06A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
miconazole 3MICONAZOLE NITRATEKroger Company063153cc-00fd-4390-bc68-90b21203678a2026-02-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
dg health miconazole 3MICONAZOLE NITRATEDolgencorp Incd84aa78d-b408-4d51-a54c-c66f6cef33f12025-11-01WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Miconazole 3MICONAZOLE NITRATESafewayb32aec61-32c0-4c7f-b843-3482433325832025-11-01WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
VAGISTAT 3MICONAZOLE NITRATECombe Incorporatede15a28cd-9e64-4e9e-8df9-829d84f1816c2025-11-01WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
miconazole 3MICONAZOLE NITRATEH E Bf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa62025-10-31WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
CareOne Miconazole 3MICONAZOLE NITRATEAmerican Sales Company84c43793-98e4-4e68-a3bc-3e72221355682025-10-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Miconazole 3MICONAZOLE NITRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED689ad530-48f9-4044-baa3-4f8b0657aeef2025-10-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Equate Miconazole 3MICONAZOLE NITRATEWALMART INC.5ade4c65-5757-4f20-b5be-f95d86363d112025-09-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Equaline Miconazole 3MICONAZOLE NITRATEUnited Natural Foods, Inc. dba UNFI89328324-72d9-4b3d-bec7-cc2e4e62f0342025-09-18WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
miconazole 3 dayMICONAZOLE NITRATEPublix Super Markets Inc9ff23f06-e97f-46ad-8601-97ca05c260a02025-09-16WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
topcare miconazole 3 combination packMICONAZOLE NITRATETopco Associates LLC0af4c06a-aa79-48ab-9857-e0f56317d8f32025-09-16WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
miconazole 3MICONAZOLE NITRATEMeijer Distribution Incfeaa0d07-013e-433f-8db4-550dc9ff737e2025-09-11WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Foster and Thrive Miconazole 3MICONAZOLE NITRATEStrategic Sourcing Services LLCba5d5b13-5604-4b8c-92b9-9f41744580292025-08-12WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Good Neighbor Pharmacy Miconazole 3MICONAZOLE NITRATEAmerisource Bergen5b87b837-3f52-40ca-b2b6-9c1f1262d90d2025-06-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Good Sense Miconazole 3MICONAZOLE NITRATEL. Perrigo Company9aeac709-001b-4617-8046-186264847ec82025-05-15WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
miconazole 3MICONAZOLE NITRATERite Aid Corporation4abee369-e8c5-4971-9545-8c015ff6eaad2023-11-08WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Signature Care Miconazole 3MICONAZOLE NITRATESafeway191e448b-0410-4102-82ae-a3387b27b2272021-02-04WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-352-032020-01-31C16284748780-19d75b9d0-e764-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-352-03Vagistat-31 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-352VAGISTAT-3 (MICONAZOLE NITRATE) KIT [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]3Legacy NDC, 1 package rows20181010_b5998ee2-d22b-4f3f-adf6-99482b1f7946.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992792{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Vagistat]) } Pack [Vagistat 3 Day Combination Pack]BPCKb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKb5998ee2-d22b-4f3f-adf6-99482b1f79463
998540miconazole nitrate 2 % Vaginal CreamPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992765miconazole nitrate 200 MG Vaginal InsertPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442Vagistat 2 % Vaginal CreamPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992792Vagistat 3 Combination PackPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791Vagistat-3 200 MG Vaginal InsertPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]SBDb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791miconazole nitrate 200 MG Vaginal Insert [Vagistat]SBDb5998ee2-d22b-4f3f-adf6-99482b1f79463
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDb5998ee2-d22b-4f3f-adf6-99482b1f79463
992765miconazole nitrate 200 MG Vaginal InsertSCDb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766miconazole 3 Day Vaginal Insert Combination PackSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
998540miconazole nitrate 2 % Vaginal CreamSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442Vagistat 2 % Vaginal CreamSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791Vagistat 200 MG Vaginal InsertSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992792Vagistat 3 Combination PackSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442Vagistat-3 2 % Vaginal CreamSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791Vagistat-3 200 MG Vaginal InsertSYb5998ee2-d22b-4f3f-adf6-99482b1f79463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-352-03764130352031 in 1 CARTONHistorical