metronidazole

Product NDC
67296-1605
11-digit product format
672961605
Labeler code
67296
Product ID
67296-1605_9c9fd4af-4f19-4691-e053-2995a90a3744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2018-01-01
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1605DDiscontinued by firm2026-08-17
excluded packagepackage67296-160567296-1605-1DDiscontinued by firm2026-08-17

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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1605-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1605-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1605-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1605-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1605-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1605-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1605-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1605-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1605-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1605-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1605-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1605-4IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1605-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1605-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1605-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1605-4IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1605-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1605-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1605-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1605-4IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1605-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1605-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1605-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1605-4IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1605-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1605-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1605-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1605-4IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1605-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1605-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1605-3IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1605-4IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1605-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1605-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1605-3IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1605-4IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1605-1IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1605-2IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1605-3IInactivated by FDAbd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206560-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2016-11-16
A206560-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2016-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206560-001AB
A206560-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206560-001METRONIDAZOLE250MGTABLET / ORALAB2016-11-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206560-002METRONIDAZOLE500MGTABLET / ORALAB2016-11-16bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206560-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206560-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206560-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206560-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206560-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206560-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206560-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206560-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206560-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206560-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206560-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206560-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206560-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206560-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206560-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206560-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206560-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206560-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206560-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206560-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206560-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206560-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206560-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206560-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206560-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206560-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206560-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206560-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206560-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67296-1605-12024-10-03metro 500
67296-1605-22024-10-03metro 500
67296-1605-32024-10-03metro 500
67296-1605-42024-10-03metro 500
67296-1605-12022-01-28metro 500
67296-1605-22022-01-28metro 500
67296-1605-32022-01-28metro 500
67296-1605-42022-01-28metro 500

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.b49a8ad0-2cf9-4386-8bf5-1b1df87b00222026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEST. MARY'S MEDICAL PARK PHARMACYe3a32908-9db1-6ca7-e053-2a95a90a82fb2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLESportpharm LLCdc8e448e-ac4e-4efc-8851-c368e31b9d692026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.ab695a3e-1721-491a-97a2-c3f617a8d9fc2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLENorthwind Health Company, LLC06bd4afb-4a45-294c-e063-6394a90a7ab12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.8f1de4ca-a005-4ca9-a43a-380429c80d6f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack356579f3-a9ed-49cf-bc0d-47b58a58cf852025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc0f108035-d2ab-49c1-9f8d-daae11f0efe02024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
METRONIDAZOLEMETRONIDAZOLEZydus Lifesciences Limitedf3ef765c-b531-4aaa-a86d-e32b7254ca482024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack9e702861-87f5-4bc0-864d-3170500201942024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEBryant Ranch Prepack1030e723-cde9-44a7-8dab-2f0932ffcc2c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLEAsclemed USA, Inc.89970965-a995-4ae4-a70b-bd2de38081e12024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560
metronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.c2dbfec8-da5b-cd2b-e053-2a95a90ad17c2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206560
application number: ANDA206560

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1605-16729616050114 TABLET in 1 BOTTLE (67296-1605-1) 14 tablet2018-01-010000-00-00NoNoCurrent
67296-1605-26729616050220 TABLET in 1 BOTTLE (67296-1605-2) 20 tablet2018-01-010000-00-00NoNoCurrent
67296-1605-36729616050330 TABLET in 1 BOTTLE (67296-1605-3) 30 tablet2018-01-010000-00-00NoNoCurrent
67296-1605-46729616050421 TABLET in 1 BOTTLE (67296-1605-4) 21 tablet2018-01-010000-00-00NoNoCurrent