Metronidazole

Product NDC
71335-1681
Requested package NDC
71335-1681-3
11-digit product format
713351681
Labeler code
71335
Product ID
71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079067
Marketing category
ANDA
Marketing start
2016-12-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-168171335-1681-3IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-168171335-1681-3IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A079067-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2009-03-13
A079067-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2009-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079067-001AB
A079067-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079067-001METRONIDAZOLE250MGTABLET / ORALAB2009-03-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A079067-002METRONIDAZOLE500MGTABLET / ORALAB2009-03-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079067-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079067-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079067-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079067-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079067-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079067-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079067-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079067-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079067-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079067-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079067-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079067-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079067-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079067-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079067-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079067-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079067-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079067-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079067-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079067-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079067-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079067-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079067-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079067-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079067-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079067-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079067-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079067-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079067-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079067-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079067-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079067-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079067-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079067-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079067-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079067-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079067-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079067-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079067-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079067-002AB1782e0a99824c…

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 · 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
8522493d-0a18-49dd-8d49-bd159f6ee332Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1681-0Metronidazole40 in 1 BOTTLETABLET404
71335-1681-1Metronidazole20 in 1 BOTTLETABLET204
71335-1681-2Metronidazole30 in 1 BOTTLETABLET304
71335-1681-3Metronidazole14 in 1 BOTTLETABLET144
71335-1681-4Metronidazole56 in 1 BOTTLETABLET564
71335-1681-5Metronidazole21 in 1 BOTTLETABLET214
71335-1681-6Metronidazole4 in 1 BOTTLETABLET44
71335-1681-7Metronidazole28 in 1 BOTTLETABLET284
71335-1681-8Metronidazole100 in 1 BOTTLETABLET1004
71335-1681-9Metronidazole60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1681METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20241121_8522493d-0a18-49dd-8d49-bd159f6ee332.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.aea4e2a1-2089-40dc-9eee-deaab4f213972025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.b85bdc1f-1ffb-40d5-a407-e8de2891996d2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack8522493d-0a18-49dd-8d49-bd159f6ee3322024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
ndc (package): 71335-1681-3
ndc (product): 71335-1681
ndc11 (package): 71335168103
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.b2bd62c2-c6ed-f459-e053-2a95a90a90eb2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
MetronidazoleMETRONIDAZOLEAlembic Pharmaceuticals Inc.b1fcf023-cdfd-45b7-b4d4-ff814f33ee792024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.937913b8-c131-6339-e053-2a95a90a4dd92024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
MetronidazoleMETRONIDAZOLEAlembic Pharmaceuticals Limitedd7455566-16aa-488a-af2a-93b55a04c02f2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067
MetronidazoleMETRONIDAZOLEAvPAK9623181f-5e3b-3695-e053-2a95a90a99f62022-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079067
application number: ANDA079067

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN8522493d-0a18-49dd-8d49-bd159f6ee3324
311681metronidazole 500 MG Oral TabletSCD8522493d-0a18-49dd-8d49-bd159f6ee3324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1681-37133516810314 TABLET in 1 BOTTLE (71335-1681-3) 14 tablet2020-08-050000-00-00NoNoCurrent