FDA.reportPublic FDA data

miconazole 3

Product NDC
11822-0209
11-digit product format
118220209
Labeler code
11822
Product ID
11822-0209_523852c0-3a16-4242-b867-d7db32e647a1
Type
HUMAN OTC DRUG
Nonproprietary name
miconazole nitrate
Dosage form
KIT
Labeler
Rite Aid Corporation
Application
ANDA075329
Marketing category
ANDA
Marketing start
2023-11-09
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 31 in 1 BLISTER PACKSUPPOSITORY3200 mg2
0113-6650-00miconazole 33 in 1 KITSUPPOSITORY200 mg2
0113-8123-00miconazole 39 g in 1 TUBECREAM9 g2 g in 100g2
0113-8123-00miconazole 31 in 1 KITCREAM2 g in 100g2
11822-0209-0miconazole 31 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0209MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]2Current NDC, 5 package rows20231111_4abee369-e8c5-4971-9545-8c015ff6eaad.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) } PackGPCK4abee369-e8c5-4971-9545-8c015ff6eaad2
998540miconazole nitrate 2 % Vaginal CreamPSN4abee369-e8c5-4971-9545-8c015ff6eaad2
992765miconazole nitrate 200 MG Vaginal InsertPSN4abee369-e8c5-4971-9545-8c015ff6eaad2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN4abee369-e8c5-4971-9545-8c015ff6eaad2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD4abee369-e8c5-4971-9545-8c015ff6eaad2
992765miconazole nitrate 200 MG Vaginal InsertSCD4abee369-e8c5-4971-9545-8c015ff6eaad2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY4abee369-e8c5-4971-9545-8c015ff6eaad2
992766miconazole 3 Day Vaginal Insert Combination PackSY4abee369-e8c5-4971-9545-8c015ff6eaad2
998540miconazole nitrate 2 % Vaginal CreamSY4abee369-e8c5-4971-9545-8c015ff6eaad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-6650-00001136650001 in 1 BLISTER PACKHistorical
0113-8123-00001138123009 g in 1 TUBE9 gHistorical
11822-0209-0118220209001 KIT in 1 CARTON (11822-0209-0) * 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 kit2023-11-09NoNoCurrent