Miconazole 7

Product NDC
59726-988
11-digit product format
597260988
Labeler code
59726
Product ID
59726-988_e318656a-0f0d-4a15-bc63-23ebd8f58ea1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
P & L Development, LLC
Application
ANDA074164
Marketing category
ANDA
Marketing start
2021-05-28
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

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 7
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998540

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
59726-988-01Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM453
59726-988-01Miconazole 71 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-988MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [P & L DEVELOPMENT, LLC]3Current NDC, Legacy NDC, 2 package rows20241106_facc7b65-0376-445a-8a3d-5180f2f9d5ff.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) } PackGPCKa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 2 % Vaginal CreamPSNa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992765miconazole nitrate 200 MG Vaginal InsertPSNa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992765miconazole nitrate 200 MG Vaginal InsertSCDa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992766miconazole 3 Day Vaginal Insert Combination PackSYa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 2 % Vaginal CreamSYa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 2 % Vaginal CreamPSNfacc7b65-0376-445a-8a3d-5180f2f9d5ff3
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDfacc7b65-0376-445a-8a3d-5180f2f9d5ff3
998540miconazole nitrate 2 % Vaginal CreamSYfacc7b65-0376-445a-8a3d-5180f2f9d5ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-988-01597260988011 TUBE, WITH APPLICATOR in 1 CARTON (59726-988-01) / 45 g in 1 TUBE, WITH APPLICATOR2021-05-280000-00-00NoNoCurrent