FDA.reportPublic FDA data

Metronidazole

Product NDC
51655-974
11-digit product format
516550974
Labeler code
51655
Product ID
51655-974_4bcf3308-c406-498f-e063-6394a90afc9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA205245
Marketing category
ANDA
Marketing start
2023-02-28
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205245-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2015-09-23
A205245-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2015-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205245-001AB
A205245-002AB

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 22:54:322026-06A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23a50c72e98297…
2026-08-01 22:54:322026-06A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205245-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205245-002AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC4e1ac737-c353-4764-bd35-dc844e75b5622026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.5cc3fd98-d579-432e-a4b5-b6d5586991a62026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf2f55405-7f21-3ccc-e053-2a95a90a195a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf7e5dacd-0bc4-4ac4-e053-6394a90a457a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
ndc (product): 51655-974
MetronidazoleMETRONIDAZOLEChartwell RX, LLC40509b3c-b725-400c-abe5-d6d5714d405d2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLEMajor Pharmaceuticals71f5ce2f-17f8-45fc-b27d-2bf982591ab32025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.a860b097-7447-a3b7-e053-2995a90a4bfd2024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d9e33638-3803-426e-a1c3-7d0cf145d92f2024-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.ae2e4bbe-8c12-4af9-e053-2a95a90af2992024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE250 mg/1

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
314106Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7e5dacd-0bc4-4ac4-e053-6394a90a457aAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-974-292026-01-29C16284748780-149896155-c15e-586f-e063-e6dba90add90Metronidazole Tablets, USP Rx only
51655-974-522026-01-29C16284748780-149896155-c15e-586f-e063-e6dba90add90Metronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-974-29Metronidazole28 in 1 BOTTLE, PLASTICTABLET284
51655-974-52Metronidazole30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-974METRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240814_f7e5dacd-0bc4-4ac4-e053-6394a90a457a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNf7e5dacd-0bc4-4ac4-e053-6394a90a457a4
314106metronidazole 250 MG Oral TabletSCDf7e5dacd-0bc4-4ac4-e053-6394a90a457a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-974-295165509742928 TABLET in 1 BOTTLE, PLASTIC (51655-974-29) 28 tablet2023-04-03NoNoCurrent
51655-974-525165509745230 TABLET in 1 BOTTLE, PLASTIC (51655-974-52) 30 tablet2023-02-28NoNoCurrent