Metronidazole
- Product NDC
- 50111-334
- 11-digit product format
- 501110334
- Labeler code
- 50111
- Product ID
- 50111-334_c6f82723-a668-4dc1-96ea-816620a5b964
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA070033
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070033-001 | METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 1984-12-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070033-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A070033-001 | METRONIDAZOLE | 500MG | TABLET / ORAL | AB | 1984-12-06 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A070033-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | 53918705-d2fe-4c6b-9501-a619a8ad3991 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 070033 ANDA070033 |
| Metronidazole | METRONIDAZOLE | REMEDYREPACK INC. | 1a28dce0-07af-401a-a6ac-1c2ee559c668 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 070033 ANDA070033 |
| Metronidazole | METRONIDAZOLE | Redpharm Drug, inc. | f426cddc-8b70-c0a7-e053-2995a90a74e0 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 070033 ANDA070033 |
| Metronidazole | METRONIDAZOLE | Bryant Ranch Prepack | e1e7e127-e99e-80e9-1606-71261658b0c1 | 2024-11-04 | Boxed warning, Warnings, Adverse reactions | 070033 ANDA070033 |
| Metronidazole | METRONIDAZOLE | Proficient Rx LP | e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205 | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | 070033 ANDA070033 |
| Metronidazole | METRONIDAZOLE | Teva Pharmaceuticals USA, Inc. | 291a45f6-ed27-4dcc-8364-358d08623797 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 070033 ANDA070033 50111-334 |
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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 291a45f6-ed27-4dcc-8364-358d08623797 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50111-334-01 | Metronidazole | 100 in 1 BOTTLE | TABLET | 100 | 18 | |
| 50111-334-02 | Metronidazole | 500 in 1 BOTTLE | TABLET | 500 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50111-334-01 | EA - Each | 50111-334 | 87298088-a4ea-4b2c-af48-a1ccb59046fe | 1 | 2012-07-24 |
| 50111-334-02 | EA - Each | 50111-334 | 7314927f-64e9-47be-8999-f744f289aadd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50111-334-01 | 50111033401 | 100 TABLET in 1 BOTTLE (50111-334-01) | 100 tablet | 1990-09-30 | 0000-00-00 | No | No | Current |
| 50111-334-02 | 50111033402 | 500 TABLET in 1 BOTTLE (50111-334-02) | 500 tablet | 1990-09-30 | 0000-00-00 | No | No | Current |