FDA.reportPublic FDA data

Metronidazole

Product NDC
0904-7126
11-digit product format
009047126
Labeler code
0904
Product ID
0904-7126_e34d3c1f-2689-469b-b82c-7f8360327553
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205245
Marketing category
ANDA
Marketing start
2017-11-29
Substance
METRONIDAZOLE
Active strength
500 mg/1
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 · 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
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
ndc (product): 0904-7126
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE500 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311681Internal RxNorm lookup
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
71f5ce2f-17f8-45fc-b27d-2bf982591ab3Available 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
0904-7126-61Metronidazole1 in 1 BLISTER PACKTABLET15
0904-7126-61Metronidazole100 in 1 CARTONTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7126-61EA - Each0904-7126d76df13c-2770-4f96-816f-6a7442327c4e12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7126METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250206_71f5ce2f-17f8-45fc-b27d-2bf982591ab3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN71f5ce2f-17f8-45fc-b27d-2bf982591ab35
311681metroNIDAZOLE 500 MG Oral TabletPSN71f5ce2f-17f8-45fc-b27d-2bf982591ab35
314106metronidazole 250 MG Oral TabletSCD71f5ce2f-17f8-45fc-b27d-2bf982591ab35
311681metronidazole 500 MG Oral TabletSCD71f5ce2f-17f8-45fc-b27d-2bf982591ab35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7126-6100904712661100 BLISTER PACK in 1 CARTON (0904-7126-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2017-11-290000-00-00NoNoCurrent