FDA.reportPublic FDA data

Metronidazole

Product NDC
16571-665
11-digit product format
165710665
Labeler code
16571
Product ID
16571-665_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA203974
Marketing category
ANDA
Marketing start
2015-05-29
Substance
METRONIDAZOLE
Active strength
250 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
A203974-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2015-05-29
A203974-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALABRS2015-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203974-001AB
A203974-002AB

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 22:54:322026-06A203974-001METRONIDAZOLE250MGTABLET / ORALAB2015-05-29a50c72e98297…
2026-08-01 22:54:322026-06A203974-002METRONIDAZOLE500MGTABLET / ORALABRS2015-05-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203974-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203974-002AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.c225a455-ec25-2213-e053-2995a90a33892026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.dc28753c-95ec-4b41-ad77-c4a66698d9db2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack2fa14353-45df-429c-8759-7d66a65f08f02024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack92e58420-1d99-4a92-b1f3-a7f791ca71872024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974
MetronidazoleMETRONIDAZOLERising Pharma Holdings, Inc.93e4f174-4fe0-4cfd-a0cf-d0963e0821072024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974
ndc (product): 16571-665
MetronidazoleMETRONIDAZOLEAurobindo Pharma Limitedf68397ee-67db-472e-8607-4300064e37df2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974
MetronidazoleMETRONIDAZOLEA-S Medication Solutionsbff2f5bd-75a4-4252-a643-c21741ae8a962023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203974
application number: ANDA203974

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2026-12-31

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 · 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
93e4f174-4fe0-4cfd-a0cf-d0963e082107Available 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
16571-665-01Metronidazole100 in 1 BOTTLETABLET1007
16571-665-50Metronidazole500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-665-01EA - Each16571-66566e71a37-6766-462c-91cd-4e3481c8077f12020-06-05
16571-665-50EA - Each16571-66545a3a143-ed32-432b-9b5f-5899dbddfdf712020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-665METRONIDAZOLE TABLET [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 2 package rows20241015_93e4f174-4fe0-4cfd-a0cf-d0963e082107.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN2fa14353-45df-429c-8759-7d66a65f08f0105
314106metronidazole 250 MG Oral TabletSCD2fa14353-45df-429c-8759-7d66a65f08f0105
314106metroNIDAZOLE 250 MG Oral TabletPSN93e4f174-4fe0-4cfd-a0cf-d0963e0821077
311681metroNIDAZOLE 500 MG Oral TabletPSN93e4f174-4fe0-4cfd-a0cf-d0963e0821077
314106metronidazole 250 MG Oral TabletSCD93e4f174-4fe0-4cfd-a0cf-d0963e0821077
311681metronidazole 500 MG Oral TabletSCD93e4f174-4fe0-4cfd-a0cf-d0963e0821077
314106metroNIDAZOLE 250 MG Oral TabletPSNbff2f5bd-75a4-4252-a643-c21741ae8a964
314106metronidazole 250 MG Oral TabletSCDbff2f5bd-75a4-4252-a643-c21741ae8a964
314106metroNIDAZOLE 250 MG Oral TabletPSNe5850e05-7d71-3210-e053-2a95a90a08372
314106metroNIDAZOLE 250 MG Oral TabletPSNe5bf5579-4f9c-f2b1-e053-2995a90ae4972
314106metronidazole 250 MG Oral TabletSCDe5850e05-7d71-3210-e053-2a95a90a08372
314106metronidazole 250 MG Oral TabletSCDe5bf5579-4f9c-f2b1-e053-2995a90ae4972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-665-0116571066501100 TABLET in 1 BOTTLE (16571-665-01) 100 tablet2015-05-290000-00-00NoNoCurrent
16571-665-5016571066550500 TABLET in 1 BOTTLE (16571-665-50) 500 tablet2015-05-290000-00-00NoNoCurrent