FDA.reportPublic FDA data

Metronidazole

Product NDC
15955-389
11-digit product format
159550389
Labeler code
15955
Product ID
15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Labs LLC
Application
ANDA208681
Marketing category
ANDA
Marketing start
2019-06-26
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
A208681-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2017-06-20
A208681-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2017-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208681-001AB
A208681-002AB

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 22:54:322026-06A208681-001METRONIDAZOLE250MGTABLET / ORALAB2017-06-20a50c72e98297…
2026-08-01 22:54:322026-06A208681-002METRONIDAZOLE500MGTABLET / ORALAB2017-06-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208681-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208681-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEAlembic Labs LLC86415209-5440-41da-abb8-e1a3d5051f912022-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208681
application number: ANDA208681
ndc (product): 15955-389

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
86415209-5440-41da-abb8-e1a3d5051f91Available 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
15955-389-01Metronidazole100 in 1 BOTTLETABLET1004
15955-389-05Metronidazole500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15955-389METRONIDAZOLE TABLET [ALEMBIC LABS LLC]4Current NDC, Legacy NDC, 2 package rows20220706_86415209-5440-41da-abb8-e1a3d5051f91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN86415209-5440-41da-abb8-e1a3d5051f914
311681metroNIDAZOLE 500 MG Oral TabletPSN86415209-5440-41da-abb8-e1a3d5051f914
314106metronidazole 250 MG Oral TabletSCD86415209-5440-41da-abb8-e1a3d5051f914
311681metronidazole 500 MG Oral TabletSCD86415209-5440-41da-abb8-e1a3d5051f914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15955-389-0115955038901100 TABLET in 1 BOTTLE (15955-389-01) 100 tablet2019-06-260000-00-00NoNoCurrent
15955-389-0515955038905500 TABLET in 1 BOTTLE (15955-389-05) 500 tablet2019-06-260000-00-00NoNoCurrent