FDA.reportPublic FDA data

Metronidazole

Product NDC
73473-303
11-digit product format
734730303
Labeler code
73473
Product ID
73473-303_a3efeca5-5c4b-432b-9537-ea2e1e67c17c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
Solaris Pharma Corporation
Application
ANDA213648
Marketing category
ANDA
Marketing start
2026-01-08
Substance
METRONIDAZOLE
Active strength
7.5 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2027-12-31

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
73473-303-702023-08-14C16284748780-10191ceaa-6729-198a-e063-dbdaa90aec3eMetronidazole Vaginal Gel, 0.75% FOR INTRAVAGINAL USE ONLY NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE
73473-303-702023-07-28C16284748780-10191ceaa-6729-198a-e063-dbdaa90aec3eMetronidazole Vaginal Gel, 0.75% FOR INTRAVAGINAL USE ONLY NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-303-70Metronidazole70 g in 1 TUBE, WITH APPLICATORGEL706
73473-303-70Metronidazole1 in 1 CARTONGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-303-70GM - Gram73473-303f83c15f6-a914-4ce7-843f-3594ff4e922112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73473-303METRONIDAZOLE GEL [SOLARIS PHARMA CORPORATION]5Current NDC, Legacy NDC, 2 package rows20250104_94a83daa-6e34-419d-849a-6f18d3b8c586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142046metroNIDAZOLE 0.75 % Vaginal GelPSN94a83daa-6e34-419d-849a-6f18d3b8c5866
142046metronidazole 0.0075 MG/MG Vaginal GelSCD94a83daa-6e34-419d-849a-6f18d3b8c5866
142046metronidazole 0.75 % Vaginal GelSY94a83daa-6e34-419d-849a-6f18d3b8c5866
142046metroNIDAZOLE 0.75 % Vaginal GelPSN2a6f8d77-a5b7-40fb-9a2e-e2778c39ba011
142046metronidazole 0.0075 MG/MG Vaginal GelSCD2a6f8d77-a5b7-40fb-9a2e-e2778c39ba011
142046metronidazole 0.75 % Vaginal GelSY2a6f8d77-a5b7-40fb-9a2e-e2778c39ba011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73473-303-70734730303701 TUBE, WITH APPLICATOR in 1 CARTON (73473-303-70) / 70 g in 1 TUBE, WITH APPLICATOR2026-01-080000-00-00NoNoCurrent