FDA.reportPublic FDA data

metronidazole

Product NDC
60760-539
11-digit product format
607600539
Labeler code
60760
Product ID
60760-539_50c8400f-2dff-8694-e063-6294a90ac938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA206560
Marketing category
ANDA
Marketing start
2022-06-17
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60760-53960760-539-40DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206560-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2016-11-16
A206560-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2016-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206560-001AB
A206560-002AB

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 22:54:322026-06A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16a50c72e98297…
2026-08-01 22:54:322026-06A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206560-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206560-002AB1a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEST. MARY'S MEDICAL PARK PHARMACYe3a32908-9db1-6ca7-e053-2a95a90a82fb2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
ndc (product): 60760-539
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.b49a8ad0-2cf9-4386-8bf5-1b1df87b00222026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLESportpharm LLCdc8e448e-ac4e-4efc-8851-c368e31b9d692026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.ab695a3e-1721-491a-97a2-c3f617a8d9fc2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLENorthwind Health Company, LLC06bd4afb-4a45-294c-e063-6394a90a7ab12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.8f1de4ca-a005-4ca9-a43a-380429c80d6f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack356579f3-a9ed-49cf-bc0d-47b58a58cf852025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc0f108035-d2ab-49c1-9f8d-daae11f0efe02024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
METRONIDAZOLEMETRONIDAZOLEZydus Lifesciences Limitedf3ef765c-b531-4aaa-a86d-e32b7254ca482024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack9e702861-87f5-4bc0-864d-3170500201942024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack1030e723-cde9-44a7-8dab-2f0932ffcc2c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEAsclemed USA, Inc.89970965-a995-4ae4-a70b-bd2de38081e12024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.c2dbfec8-da5b-cd2b-e053-2a95a90ad17c2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3a32908-9db1-6ca7-e053-2a95a90a82fbAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-539-14metronidazole14 in 1 BOTTLE, PLASTICTABLET144
60760-539-40metronidazole40 in 1 BOTTLE, PLASTICTABLET404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-539-14EA - Each60760-539e8fa175c-99ba-4e33-9f54-5a6cea7a0e5912022-08-04
60760-539-40EA - Each60760-539228e4cd4-aa12-48e0-b13e-0a74a47035f712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-539METRONIDAZOLE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 2 package rows20230124_e3a32908-9db1-6ca7-e053-2a95a90a82fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNe3a32908-9db1-6ca7-e053-2a95a90a82fb4
311681metronidazole 500 MG Oral TabletSCDe3a32908-9db1-6ca7-e053-2a95a90a82fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-539-146076005391414 TABLET in 1 BOTTLE, PLASTIC (60760-539-14) 14 tablet2022-06-170000-00-00NoNoCurrent
60760-539-406076005394040 in 1 BOTTLE, PLASTICHistorical