FDA.reportPublic FDA data

Metronidazole

Product NDC
0713-0575
11-digit product format
007130575
Labeler code
0713
Product ID
0713-0575_00beeda9-9cf9-730b-e063-6294a90a8ad0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA216323
Marketing category
ANDA
Marketing start
2023-07-12
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216323-001METRONIDAZOLEMETRONIDAZOLE0.75%GEL / VAGINALAB2023-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216323-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216323-001METRONIDAZOLE0.75%GEL / VAGINALAB2023-07-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216323-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLECosette Pharmaceuticals, Inc.d76810d5-11b4-4b5e-b850-230f59376c342023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216323
application number: ANDA216323
ndc (product): 0713-0575

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE7.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
140QMO216EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
142046Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d76810d5-11b4-4b5e-b850-230f59376c34Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0575-71Metronidazole70 g in 1 TUBE, WITH APPLICATORGEL701
0713-0575-71Metronidazole1 in 1 CARTONGEL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0575-71GM - Gram0713-0575757d56a4-effa-4c9c-b736-75523b93901312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0575METRONIDAZOLE GEL [COSETTE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230719_d76810d5-11b4-4b5e-b850-230f59376c34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142046metroNIDAZOLE 0.75 % Vaginal GelPSN1e19fee8-7bde-a0c7-e063-6294a90a647a1
142046metroNIDAZOLE 0.75 % Vaginal GelPSNd76810d5-11b4-4b5e-b850-230f59376c341
142046metronidazole 0.0075 MG/MG Vaginal GelSCD1e19fee8-7bde-a0c7-e063-6294a90a647a1
142046metronidazole 0.0075 MG/MG Vaginal GelSCDd76810d5-11b4-4b5e-b850-230f59376c341
142046metronidazole 0.75 % Vaginal GelSY1e19fee8-7bde-a0c7-e063-6294a90a647a1
142046metronidazole 0.75 % Vaginal GelSYd76810d5-11b4-4b5e-b850-230f59376c341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0713-0575-71007130575711 TUBE, WITH APPLICATOR in 1 CARTON (0713-0575-71) / 70 g in 1 TUBE, WITH APPLICATOR2023-07-12NoNoCurrent