FDA.reportPublic FDA data

Metronidazole

Product NDC
51672-4164
11-digit product format
516724164
Labeler code
51672
Product ID
51672-4164_6f4c6a7f-eee9-45b2-b0ed-64377aab9d49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA204651
Marketing category
ANDA
Marketing start
2017-03-14
Substance
METRONIDAZOLE
Active strength
10 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51672-4164DDiscontinued by firm2026-07-31
excluded packagepackage51672-416451672-4164-3DDiscontinued by firm2026-07-31
excluded packagepackage51672-416451672-4164-6DDiscontinued by firm2026-07-31
excluded packagepackage51672-416451672-4164-9DDiscontinued by firm2026-07-31

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
A204651-001METRONIDAZOLEMETRONIDAZOLE1%GEL / TOPICALAB2017-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204651-001AB

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 22:54:322026-06A204651-001METRONIDAZOLE1%GEL / TOPICALAB2017-03-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204651-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5a504f74-bccd-433a-bd5b-6822f98c34df2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204651
application number: ANDA204651
ndc (product): 51672-4164
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5842a554-58d1-4ee4-99aa-1e6029a69be22026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204651
application number: ANDA204651

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE10 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
577237Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a504f74-bccd-433a-bd5b-6822f98c34dfAvailable 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
51672-4164-3Metronidazole1 in 1 CARTONGEL16
51672-4164-3Metronidazole60 g in 1 TUBEGEL606
51672-4164-6Metronidazole1 in 1 CARTONGEL16
51672-4164-6Metronidazole45 g in 1 TUBEGEL456
51672-4164-9Metronidazole55 g in 1 BOTTLE, PUMPGEL556
51672-4164-9Metronidazole1 in 1 CARTONGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4164-3GM - Gram51672-41647478a107-2b52-4b1e-bcaa-bb66a0fa555512017-04-05
51672-4164-9GM - Gram51672-416467ab368e-2499-4522-bc1c-fa9198290fe212017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4164METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20190510_5a504f74-bccd-433a-bd5b-6822f98c34df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577237metroNIDAZOLE 1 % Topical GelPSN5a504f74-bccd-433a-bd5b-6822f98c34df6
577237metronidazole 0.01 MG/MG Topical GelSCD5a504f74-bccd-433a-bd5b-6822f98c34df6
577237metronidazole 1 % Topical GelSY5a504f74-bccd-433a-bd5b-6822f98c34df6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4164-3516724164031 TUBE in 1 CARTON (51672-4164-3) / 60 g in 1 TUBE1 tube2017-03-140000-00-00NoNoCurrent
51672-4164-6516724164061 TUBE in 1 CARTON (51672-4164-6) / 45 g in 1 TUBE1 tube2017-03-140000-00-00NoNoCurrent
51672-4164-9516724164091 BOTTLE, PUMP in 1 CARTON (51672-4164-9) / 55 g in 1 BOTTLE, PUMP2017-08-150000-00-00NoNoCurrent