FDA.reportPublic FDA data

Miconazole 3

Product NDC
51316-689
11-digit product format
513160689
Labeler code
51316
Product ID
51316-689_e55b2ee9-0e90-4788-88b1-ff25dc81b1ce
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA075329
Marketing category
ANDA
Marketing start
2024-04-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 3
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 998540

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
0113-6650-00Miconazole 33 in 1 KITSUPPOSITORY200 mg2
0113-6650-00Miconazole 31 in 1 BLISTER PACKSUPPOSITORY3200 mg2
0113-8123-00Miconazole 31 in 1 KITCREAM2 g in 100g2
0113-8123-00Miconazole 39 g in 1 TUBECREAM9 g2 g in 100g2
51316-689-00Miconazole 31 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-689MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1Current NDC, 5 package rows20240606_689ad530-48f9-4044-baa3-4f8b0657aeef.zip

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) } PackGPCK689ad530-48f9-4044-baa3-4f8b0657aeef2
998540miconazole nitrate 2 % Vaginal CreamPSN689ad530-48f9-4044-baa3-4f8b0657aeef2
992765miconazole nitrate 200 MG Vaginal InsertPSN689ad530-48f9-4044-baa3-4f8b0657aeef2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN689ad530-48f9-4044-baa3-4f8b0657aeef2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD689ad530-48f9-4044-baa3-4f8b0657aeef2
992765miconazole nitrate 200 MG Vaginal InsertSCD689ad530-48f9-4044-baa3-4f8b0657aeef2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY689ad530-48f9-4044-baa3-4f8b0657aeef2
992766miconazole 3 Day Vaginal Insert Combination PackSY689ad530-48f9-4044-baa3-4f8b0657aeef2
998540miconazole nitrate 2 % Vaginal CreamSY689ad530-48f9-4044-baa3-4f8b0657aeef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-6650-00001136650003 in 1 KITHistorical
0113-8123-00001138123001 in 1 KITHistorical
51316-689-00513160689001 KIT in 1 CARTON (51316-689-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE1 kit2024-04-17NoNoCurrent