FDA.reportPublic FDA data

metronidazole vaginal

Product NDC
50090-4809
11-digit product format
500904809
Labeler code
50090
Product ID
50090-4809_e4653947-38a7-4bd4-a627-a93368f5d1d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
A-S Medication Solutions
Application
ANDA211786
Marketing category
ANDA
Marketing start
2019-07-08
Substance
METRONIDAZOLE
Active strength
7.5 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
metronidazole vaginal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE7.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui142046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4809-02023-02-07C16284748780-1f386c64a-331f-0266-e053-dadaa90a7c1aMetronidazole Vaginal Gel, 0.75%
50090-4809-02023-02-07C16284748780-1f386c64a-331f-0266-e053-dadaa90a7c1aMetronidazole Vaginal Gel, 0.75%
50090-4809-02023-01-30C16284748780-1f386c64a-331f-0266-e053-dadaa90a7c1aMetronidazole Vaginal Gel, 0.75%
50090-4809-02023-01-30C16284748780-1f386c64a-331f-0266-e053-dadaa90a7c1aMetronidazole Vaginal Gel, 0.75%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4809-0metronidazole vaginal1 in 1 CARTONGEL17
50090-4809-0metronidazole vaginal70 g in 1 TUBEGEL707

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4809-0GM - Gram50090-48098174c2c0-c972-462a-8260-f2ca584c150c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4809METRONIDAZOLE VAGINAL (METRONIDAZOLE) GEL [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240731_58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142046metroNIDAZOLE 0.75 % Vaginal GelPSN58ce793b-9b6a-4cd7-94ae-215dbf9e2ef77
142046metronidazole 0.0075 MG/MG Vaginal GelSCD58ce793b-9b6a-4cd7-94ae-215dbf9e2ef77
142046metronidazole 0.75 % Vaginal GelSY58ce793b-9b6a-4cd7-94ae-215dbf9e2ef77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4809-0500904809001 TUBE in 1 CARTON (50090-4809-0) / 70 g in 1 TUBE1 tube2019-12-260000-00-00NoNoCurrent