Metronidazole

Product NDC
50090-2512
11-digit product format
500902512
Labeler code
50090
Product ID
50090-2512_2287ed6a-be34-4f02-91ae-6192733c6be4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070033
Marketing category
ANDA
Marketing start
1990-09-30
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 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2512IInactivated by FDA2026-08-03
excluded productproduct50090-2512DDiscontinued by firm2026-08-03
excluded packagepackage50090-251250090-2512-0IInactivated by FDA2026-08-03
excluded packagepackage50090-251250090-2512-3IInactivated by FDA2026-08-03
excluded packagepackage50090-251250090-2512-4IInactivated by FDA2026-08-03
excluded packagepackage50090-251250090-2512-6IInactivated by FDA2026-08-03
excluded packagepackage50090-251250090-2512-9IInactivated by FDA2026-08-03
excluded packagepackage50090-251250090-2512-0DDiscontinued by firm2026-08-03
excluded packagepackage50090-251250090-2512-3DDiscontinued by firm2026-08-03
excluded packagepackage50090-251250090-2512-4DDiscontinued by firm2026-08-03
excluded packagepackage50090-251250090-2512-6DDiscontinued by firm2026-08-03
excluded packagepackage50090-251250090-2512-9DDiscontinued by firm2026-08-03

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 3 · 162 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-0IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-9IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-9DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-6DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2512-4IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-0IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-9IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-9DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-6DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2512-4IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-0IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-9IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-9DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-4DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-6DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2512-4IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-0IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-9IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-9DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-4DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-6DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2512-4IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-0IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-9IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-9DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-4DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-6DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2512-4IInactivated by FDAcfe11265f3b6…090c488252e2…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070033-001METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB1984-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070033-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-063f01610625f2…
2019-09-15 20:21 UTC2019-09A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070033-001METRONIDAZOLE500MGTABLET / ORALAB1984-12-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070033-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070033-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070033-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070033-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070033-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070033-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070033-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070033-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070033-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070033-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070033-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070033-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070033-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070033-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070033-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070033-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070033-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070033-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070033-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070033-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070033-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070033-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070033-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070033-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070033-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070033-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070033-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070033-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070033-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070033-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070033-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070033-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070033-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070033-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070033-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070033-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070033-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070033-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070033-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070033-001AB1cb3db0bc1861…

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
50090-2512-0Metronidazole4 in 1 BOTTLETABLET49
50090-2512-3Metronidazole14 in 1 BOTTLETABLET149
50090-2512-4Metronidazole21 in 1 BOTTLETABLET219
50090-2512-6Metronidazole28 in 1 BOTTLETABLET289
50090-2512-9Metronidazole20 in 1 BOTTLETABLET209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2512-0EA - Each50090-25129d171dcb-5195-48fd-937a-23c61e56313912019-03-12
50090-2512-3EA - Each50090-251258b2c133-d8d4-474b-9f74-5a8e2938a87912019-03-12
50090-2512-4EA - Each50090-2512f60e8fa7-fbcc-4d0d-bf07-25a9518dd5fc12019-03-12
50090-2512-6EA - Each50090-25127453c30c-9822-41d8-bfe9-bb2d25fc7d3212019-03-12
50090-2512-9EA - Each50090-25121ea5f6d3-d0f4-4a05-805a-a9f08e872eb312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2512METRONIDAZOLE TABLET [A-S MEDICATION SOLUTIONS]9Legacy NDC, 5 package rows20210227_c7bc09dc-32a5-4163-a30e-1b598119ee97.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.53918705-d2fe-4c6b-9501-a619a8ad39912026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070033
application number: ANDA070033
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.1a28dce0-07af-401a-a6ac-1c2ee559c6682026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070033
application number: ANDA070033
MetronidazoleMETRONIDAZOLERedpharm Drug, inc.f426cddc-8b70-c0a7-e053-2995a90a74e02025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070033
application number: ANDA070033
MetronidazoleMETRONIDAZOLEBryant Ranch Prepacke1e7e127-e99e-80e9-1606-71261658b0c12024-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070033
application number: ANDA070033
MetronidazoleMETRONIDAZOLEProficient Rx LPe313c7d9-fb7b-4d0f-bccf-cc72ac5ef2052024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070033
application number: ANDA070033
MetronidazoleMETRONIDAZOLETeva Pharmaceuticals USA, Inc.291a45f6-ed27-4dcc-8364-358d086237972024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070033
application number: ANDA070033

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNc7bc09dc-32a5-4163-a30e-1b598119ee979
311681metronidazole 500 MG Oral TabletSCDc7bc09dc-32a5-4163-a30e-1b598119ee979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2512-0500902512004 TABLET in 1 BOTTLE (50090-2512-0) 4 tablet2016-10-240000-00-00NoNoCurrent
50090-2512-35009025120314 TABLET in 1 BOTTLE (50090-2512-3) 14 tablet2016-10-200000-00-00NoNoCurrent
50090-2512-45009025120421 TABLET in 1 BOTTLE (50090-2512-4) 21 tablet2016-11-210000-00-00NoNoCurrent
50090-2512-65009025120628 TABLET in 1 BOTTLE (50090-2512-6) 28 tablet2016-10-140000-00-00NoNoCurrent
50090-2512-95009025120920 TABLET in 1 BOTTLE (50090-2512-9) 20 tablet2016-10-270000-00-00NoNoCurrent