Metronidazole
- Product NDC
- 71335-1681
- Requested package NDC
- 71335-1681-2
- 11-digit product format
- 713351681
- Labeler code
- 71335
- Product ID
- 71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA079067
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1681 | 71335-1681-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1681 | 71335-1681-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079067-001 | METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | |
| A079067-002 | METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079067-001 | AB |
| A079067-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A079067-001 | METRONIDAZOLE | 250MG | TABLET / ORAL | AB | 2009-03-13 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A079067-002 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 2009-03-13 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079067-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079067-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079067-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079067-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079067-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079067-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079067-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079067-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079067-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079067-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079067-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079067-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079067-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079067-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079067-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079067-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079067-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079067-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A079067-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A079067-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079067-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079067-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079067-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079067-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079067-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079067-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A079067-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A079067-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079067-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079067-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A079067-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A079067-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A079067-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A079067-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A079067-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079067-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A079067-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A079067-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A079067-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A079067-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metronidazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METRONIDAZOLE | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 140QMO216E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 311681 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8522493d-0a18-49dd-8d49-bd159f6ee332 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55 | Product name | 5 | 20251024 |
| 7f6d14e0-4366-41bc-a4a9-b74c79a20e17 | Product name | 1 | 20250623 |
| e6d321b0-0e5e-7da6-f043-92b6a91f00a1 | Product name | 5 | 20250515 |
| e1aac33b-94ae-4ee9-905b-299f7263853b | Product name | 3 | 20250124 |
| 16642716-d28a-4f90-8dcb-3921cd8c8109 | Product name | 4 | 20240516 |
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| a5070875-62bb-61e1-fd46-8f7054197a40 | Product name | 8 | 20180215 |
| 0add4de9-d152-3375-3390-1123dddc5e3d | Product name | 1 | 20140508 |
| 33ca0fcc-1011-92dc-50a9-a383683eed1e | Product name | 1 | 20140508 |
| 53f39d9f-cd3f-04e1-c668-d4580719d57d | Product name | 1 | 20140508 |
| a804000f-b74f-0b5d-d17b-aa767c286ddb | Product name | 1 | 20140508 |
| a91ea265-6e02-c08f-93c8-686d54180529 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-1681-0 | Metronidazole | 40 in 1 BOTTLE | TABLET | 40 | 4 | |
| 71335-1681-1 | Metronidazole | 20 in 1 BOTTLE | TABLET | 20 | 4 | |
| 71335-1681-2 | Metronidazole | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 71335-1681-3 | Metronidazole | 14 in 1 BOTTLE | TABLET | 14 | 4 | |
| 71335-1681-4 | Metronidazole | 56 in 1 BOTTLE | TABLET | 56 | 4 | |
| 71335-1681-5 | Metronidazole | 21 in 1 BOTTLE | TABLET | 21 | 4 | |
| 71335-1681-6 | Metronidazole | 4 in 1 BOTTLE | TABLET | 4 | 4 | |
| 71335-1681-7 | Metronidazole | 28 in 1 BOTTLE | TABLET | 28 | 4 | |
| 71335-1681-8 | Metronidazole | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 71335-1681-9 | Metronidazole | 60 in 1 BOTTLE | TABLET | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1681 | METRONIDAZOLE TABLET [BRYANT RANCH PREPACK] | 4 | Current NDC, Legacy NDC, 10 package rows | 20241121_8522493d-0a18-49dd-8d49-bd159f6ee332.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metronidazole | METRONIDAZOLE | PD-Rx Pharmaceuticals, Inc. | aea4e2a1-2089-40dc-9eee-deaab4f21397 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
| Metronidazole | METRONIDAZOLE | PD-Rx Pharmaceuticals, Inc. | b85bdc1f-1ffb-40d5-a407-e8de2891996d | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
| Metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | 8522493d-0a18-49dd-8d49-bd159f6ee332 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 71335-1681-2 71335-1681 71335168102 |
| Metronidazole | METRONIDAZOLE | NuCare Pharmaceuticals,Inc. | b2bd62c2-c6ed-f459-e053-2a95a90a90eb | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
| Metronidazole | METRONIDAZOLE | Alembic Pharmaceuticals Inc. | b1fcf023-cdfd-45b7-b4d4-ff814f33ee79 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
| Metronidazole | METRONIDAZOLE | NuCare Pharmaceuticals,Inc. | 937913b8-c131-6339-e053-2a95a90a4dd9 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
| Metronidazole | METRONIDAZOLE | Alembic Pharmaceuticals Limited | d7455566-16aa-488a-af2a-93b55a04c02f | 2023-01-30 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
| Metronidazole | METRONIDAZOLE | AvPAK | 9623181f-5e3b-3695-e053-2a95a90a99f6 | 2022-05-06 | Boxed warning, Warnings, Adverse reactions | 079067 ANDA079067 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311681 | metroNIDAZOLE 500 MG Oral Tablet | PSN | 8522493d-0a18-49dd-8d49-bd159f6ee332 | 4 |
| 311681 | metronidazole 500 MG Oral Tablet | SCD | 8522493d-0a18-49dd-8d49-bd159f6ee332 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1681-2 | 71335168102 | 30 TABLET in 1 BOTTLE (71335-1681-2) | 30 tablet | 2020-08-04 | 0000-00-00 | No | No | Current |