metronidazole

Product NDC
67296-1806
11-digit product format
672961806
Labeler code
67296
Product ID
67296-1806_b95abf1e-4240-23d2-e053-2995a90a7c0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA070772
Marketing category
ANDA
Marketing start
2019-11-22
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1806IInactivated by FDA2026-08-03
excluded packagepackage67296-180667296-1806-3IInactivated by FDA2026-08-03
excluded packagepackage67296-180667296-1806-7IInactivated by FDA2026-08-03
excluded packagepackage67296-180667296-1806-8IInactivated by FDA2026-08-03

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1806-8557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1806-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1806-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1806-88af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1806-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1806-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1806-8834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1806-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1806-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1806-81332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1806-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1806-71332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070772-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB1986-07-16
A070772-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB1986-07-16
A070772-003METRONIDAZOLEMETRONIDAZOLE125MGTABLET / ORAL2024-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070772-001AB
A070772-002AB

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 · 91 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070772-003METRONIDAZOLE125MGTABLET / ORAL2024-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070772-001METRONIDAZOLE250MGTABLET / ORALAB1986-07-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A070772-002METRONIDAZOLE500MGTABLET / ORALAB1986-07-165d02ea3f76ae…

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 UTC2026-02A070772-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070772-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070772-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070772-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070772-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070772-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070772-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070772-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070772-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070772-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070772-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070772-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070772-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070772-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070772-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070772-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070772-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070772-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070772-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070772-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070772-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070772-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070772-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070772-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070772-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070772-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070772-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A070772-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070772-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070772-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070772-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A070772-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070772-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A070772-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070772-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A070772-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070772-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A070772-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070772-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A070772-002AB1782e0a99824c…

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
67296-1806-3metronidazole30 in 1 BOTTLETABLET303
67296-1806-7metronidazole14 in 1 BOTTLETABLET143
67296-1806-8metronidazole21 in 1 BOTTLETABLET213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1806METRONIDAZOLE TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 3 package rows20240727_afed6bd4-7c91-6543-e053-2995a90a1bd7.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
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEMethod Pharmaceuticals LLC2ae49bf4-a23b-bdcc-e063-6294a90a80a92026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC9ed89bfc-ccf3-4e6c-924f-2a14bf82163f2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
MetronidazoleMETRONIDAZOLEAmerican Health Packagingc90da73c-e48e-411a-bd75-0b107f1141cc2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEBryant Ranch Prepackac7e80ce-6174-4246-a955-a92adc5165712025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEGolden State Medical Supply, Inc.a6ceb47b-d0b0-d377-e053-2995a90a463e2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEGolden State Medical Supply, Inc.a6ce16b7-25c5-48aa-e053-2a95a90aa9472025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEAMICI PHARMA INC9f1fec88-097f-42b9-a36f-214648d7eebb2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772
metronidazoleMETRONIDAZOLEAMICI PHARMA INC4920fcf7-5ceb-46e9-82e0-dc508900bb912025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070772
application number: ANDA070772

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNafed6bd4-7c91-6543-e053-2995a90a1bd73
311681metronidazole 500 MG Oral TabletSCDafed6bd4-7c91-6543-e053-2995a90a1bd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1806-36729618060330 TABLET in 1 BOTTLE (67296-1806-3) 30 tablet2019-11-220000-00-00NoNoCurrent
67296-1806-76729618060714 TABLET in 1 BOTTLE (67296-1806-7) 14 tablet2019-11-220000-00-00NoNoCurrent
67296-1806-86729618060821 TABLET in 1 BOTTLE (67296-1806-8) 21 tablet2021-01-010000-00-00NoNoCurrent