FDA.reportPublic FDA data

metronidazole

Product NDC
58657-934
11-digit product format
586570934
Labeler code
58657
Product ID
58657-934_51018185-a67f-bf2c-e063-6394a90adca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals LLC
Application
ANDA070772
Marketing category
ANDA
Marketing start
2025-07-01
Substance
METRONIDAZOLE
Active strength
500 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070772-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB1986-07-16
A070772-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB1986-07-16
A070772-003METRONIDAZOLEMETRONIDAZOLE125MGTABLET / ORAL2024-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070772-001AB
A070772-002AB

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 22:54:322026-06A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16a50c72e98297…
2026-08-01 22:54:322026-06A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16a50c72e98297…
2026-08-01 22:54:322026-06A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A070772-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A070772-002AB1a50c72e98297…

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
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEMethod Pharmaceuticals LLC2ae49bf4-a23b-bdcc-e063-6294a90a80a92026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
ndc (product): 58657-934
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC9ed89bfc-ccf3-4e6c-924f-2a14bf82163f2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
MetronidazoleMETRONIDAZOLEAmerican Health Packagingc90da73c-e48e-411a-bd75-0b107f1141cc2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEBryant Ranch Prepackac7e80ce-6174-4246-a955-a92adc5165712025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEGolden State Medical Supply, Inc.a6ceb47b-d0b0-d377-e053-2995a90a463e2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEGolden State Medical Supply, Inc.a6ce16b7-25c5-48aa-e053-2a95a90aa9472025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEAMICI PHARMA INC9f1fec88-097f-42b9-a36f-214648d7eebb2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEAMICI PHARMA INC4920fcf7-5ceb-46e9-82e0-dc508900bb912025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311681Internal RxNorm lookup
314106Internal RxNorm lookup
2702348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ae49bf4-a23b-bdcc-e063-6294a90a80a9Available 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
58657-934-01metronidazole100 in 1 CARTONTABLET1004
58657-934-05metronidazole50 in 1 CARTONTABLET504
58657-934-10metronidazole1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-934-01EA - Each58657-934cb7c8110-70c2-4509-8fe9-9941a589487612025-10-14
58657-934-05EA - Each58657-934f9fae061-83e9-4be4-b888-b126045cc86f12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702348metroNIDAZOLE 125 MG Oral TabletPSN2ae49bf4-a23b-bdcc-e063-6294a90a80a94
314106metroNIDAZOLE 250 MG Oral TabletPSN2ae49bf4-a23b-bdcc-e063-6294a90a80a94
311681metroNIDAZOLE 500 MG Oral TabletPSN2ae49bf4-a23b-bdcc-e063-6294a90a80a94
2702348metronidazole 125 MG Oral TabletSCD2ae49bf4-a23b-bdcc-e063-6294a90a80a94
314106metronidazole 250 MG Oral TabletSCD2ae49bf4-a23b-bdcc-e063-6294a90a80a94
311681metronidazole 500 MG Oral TabletSCD2ae49bf4-a23b-bdcc-e063-6294a90a80a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-934-0158657093401100 BLISTER PACK in 1 CARTON (58657-934-01) / 1 TABLET in 1 BLISTER PACK (58657-934-10) 100 blister pack2025-07-01NoNoCurrent
58657-934-055865709340550 BLISTER PACK in 1 CARTON (58657-934-05) / 1 TABLET in 1 BLISTER PACK (58657-934-10) 50 blister pack2025-07-01NoNoCurrent
58657-934-10586570934101 in 1 BLISTER PACKHistorical