Metronidazole

Product NDC
23155-651
11-digit product format
231550651
Labeler code
23155
Product ID
23155-651_a144e3b5-1edf-446a-99cd-51f4f8ce8dc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205245
Marketing category
ANDA
Marketing start
2017-11-29
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
A205245-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2015-09-23
A205245-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205245-001AB
A205245-002AB

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 UTC2026-02A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205245-001METRONIDAZOLE250MGTABLET / ORALAB2015-09-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A205245-002METRONIDAZOLE500MGTABLET / ORALAB2015-09-23782e0a99824c…

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 UTC2026-02A205245-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205245-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205245-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205245-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205245-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205245-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205245-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205245-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205245-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205245-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205245-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205245-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205245-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205245-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205245-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205245-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205245-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205245-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205245-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205245-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205245-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205245-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205245-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205245-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205245-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205245-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205245-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205245-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205245-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205245-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205245-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205245-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205245-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205245-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205245-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205245-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205245-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205245-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205245-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205245-002AB1782e0a99824c…

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
d9e33638-3803-426e-a1c3-7d0cf145d92fAvailable 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
23155-651-01Metronidazole100 in 1 BOTTLE, PLASTICTABLET10011
23155-651-05Metronidazole500 in 1 BOTTLE, PLASTICTABLET50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-651-01EA - Each23155-651900db3b0-5402-47f8-bbfb-11fda2e343ae12018-01-12
23155-651-05EA - Each23155-651111b2871-53e7-4bcd-a2ba-7b0dd7e2462212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-651METRONIDAZOLE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20240820_d9e33638-3803-426e-a1c3-7d0cf145d92f.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.5cc3fd98-d579-432e-a4b5-b6d5586991a62026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC4e1ac737-c353-4764-bd35-dc844e75b5622026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf2f55405-7f21-3ccc-e053-2a95a90a195a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf7e5dacd-0bc4-4ac4-e053-6394a90a457a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLEChartwell RX, LLC40509b3c-b725-400c-abe5-d6d5714d405d2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLEMajor Pharmaceuticals71f5ce2f-17f8-45fc-b27d-2bf982591ab32025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.a860b097-7447-a3b7-e053-2995a90a4bfd2024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
MetronidazoleMETRONIDAZOLEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d9e33638-3803-426e-a1c3-7d0cf145d92f2024-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245
ndc (product): 23155-651
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.ae2e4bbe-8c12-4af9-e053-2a95a90af2992024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205245
application number: ANDA205245

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNd9e33638-3803-426e-a1c3-7d0cf145d92f11
311681metroNIDAZOLE 500 MG Oral TabletPSNd9e33638-3803-426e-a1c3-7d0cf145d92f11
314106metronidazole 250 MG Oral TabletSCDd9e33638-3803-426e-a1c3-7d0cf145d92f11
311681metronidazole 500 MG Oral TabletSCDd9e33638-3803-426e-a1c3-7d0cf145d92f11
314106metroNIDAZOLE 250 MG Oral TabletPSN71f5ce2f-17f8-45fc-b27d-2bf982591ab35
314106metroNIDAZOLE 250 MG Oral TabletPSNa860b097-7447-a3b7-e053-2995a90a4bfd5
311681metroNIDAZOLE 500 MG Oral TabletPSN71f5ce2f-17f8-45fc-b27d-2bf982591ab35
314106metronidazole 250 MG Oral TabletSCD71f5ce2f-17f8-45fc-b27d-2bf982591ab35
314106metronidazole 250 MG Oral TabletSCDa860b097-7447-a3b7-e053-2995a90a4bfd5
311681metronidazole 500 MG Oral TabletSCD71f5ce2f-17f8-45fc-b27d-2bf982591ab35
314106metroNIDAZOLE 250 MG Oral TabletPSNf7e5dacd-0bc4-4ac4-e053-6394a90a457a4
314106metronidazole 250 MG Oral TabletSCDf7e5dacd-0bc4-4ac4-e053-6394a90a457a4
314106metroNIDAZOLE 250 MG Oral TabletPSNae2e4bbe-8c12-4af9-e053-2a95a90af2993
314106metronidazole 250 MG Oral TabletSCDae2e4bbe-8c12-4af9-e053-2a95a90af2993

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-651-0123155065101100 TABLET in 1 BOTTLE, PLASTIC (23155-651-01) 100 tablet2017-11-290000-00-00NoNoCurrent
23155-651-0523155065105500 TABLET in 1 BOTTLE, PLASTIC (23155-651-05) 500 tablet2017-11-290000-00-00NoNoCurrent