Metronidazole

Product NDC
70934-436
11-digit product format
709340436
Labeler code
70934
Product ID
70934-436_b789d763-dc8f-af4e-e053-2a95a90acb90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA070033
Marketing category
ANDA
Marketing start
2019-09-09
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-436IInactivated by FDA2026-08-03
excluded packagepackage70934-43670934-436-14IInactivated by FDA2026-08-03
excluded packagepackage70934-43670934-436-21IInactivated 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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-436-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-436-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-436-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-436-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-436-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-436-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-436-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-436-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-436-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-436-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-436-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-436-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-436-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-436-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-436-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-436-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-436-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-436-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-436-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-436-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-436-14367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-436-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-436-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-436-21557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70934-436-148af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70934-436-218af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-436-14834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-436-21834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-436-141332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-436-211332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70934-436-14fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70934-436-21fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70934-436-1486f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70934-436-2186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70934-436-14bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70934-436-21bd6a592717d7…303034d00443…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-436-142022-01-28C16284748780-1d6a99b3a-019a-a426-e053-dadaa90af4c2Metronidazole Tablets USP
70934-436-212022-01-28C16284748780-1d6a99b3a-019a-a426-e053-dadaa90af4c2Metronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-436-14Metronidazole14 in 1 BOTTLE, PLASTICTABLET142
70934-436-21Metronidazole21 in 1 BOTTLE, PLASTICTABLET212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-436-21EA - Each70934-4365b0e47f2-158f-4593-be8e-df16be9d690e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-436METRONIDAZOLE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 2 package rows20201231_96230db1-1c79-72e3-e053-2995a90ad73f.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 TabletPSN96230db1-1c79-72e3-e053-2995a90ad73f2
311681metronidazole 500 MG Oral TabletSCD96230db1-1c79-72e3-e053-2995a90ad73f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-436-147093404361414 TABLET in 1 BOTTLE, PLASTIC (70934-436-14) 14 tablet2019-09-090000-00-00NoNoCurrent
70934-436-217093404362121 TABLET in 1 BOTTLE, PLASTIC (70934-436-21) 21 tablet2020-09-010000-00-00NoNoCurrent