Signature Care Miconazole 1

Product NDC
21130-040
11-digit product format
211300040
Labeler code
21130
Product ID
21130-040_44d0726a-3148-445d-adf6-9dc6204fa0db
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Safeway
Application
ANDA079114
Marketing category
ANDA
Marketing start
2015-09-28
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Signature Care Miconazole 1
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992774, 992775, 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
21130-040-00Signature Care Miconazole 11 in 1 CARTONKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
GELATININACTIVE INGREDIENT2G86QN327LSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50SIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5SIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1
WATERINACTIVE INGREDIENT059QF0KO0RSIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-040SIGNATURE CARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [SAFEWAY]5Current NDC, Legacy NDC, 1 package rows20221122_5129e042-421e-41e3-a0be-90f12d12b40b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK5129e042-421e-41e3-a0be-90f12d12b40b5
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN5129e042-421e-41e3-a0be-90f12d12b40b5
992774miconazole nitrate 1200 MG Vaginal InsertPSN5129e042-421e-41e3-a0be-90f12d12b40b5
998540miconazole nitrate 2 % Vaginal CreamPSN5129e042-421e-41e3-a0be-90f12d12b40b5
992774miconazole nitrate 1200 MG Vaginal InsertSCD5129e042-421e-41e3-a0be-90f12d12b40b5
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD5129e042-421e-41e3-a0be-90f12d12b40b5
992774miconazole nitrate 1.2 GM Vaginal InsertSY5129e042-421e-41e3-a0be-90f12d12b40b5
998540miconazole nitrate 2 % Vaginal CreamSY5129e042-421e-41e3-a0be-90f12d12b40b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-040-00211300040001 KIT in 1 CARTON (21130-040-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE1 kit2015-09-280000-00-00NoNoCurrent