Trimethoprim
- Product NDC
- 70954-541
- 11-digit product format
- 709540541
- Labeler code
- 70954
- Product ID
- 70954-541_95a1572c-6109-4d1f-bf92-262015a7654e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA216393
- Marketing category
- ANDA
- Marketing start
- 2022-11-04
- Substance
- TRIMETHOPRIM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Trimethoprim
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRIMETHOPRIM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AN164J8Y0X |
| Rxcui | 198332 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-541-10 | Trimethoprim | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-541 | TRIMETHOPRIM TABLET [NOVITIUM PHARMA LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221104_95a1572c-6109-4d1f-bf92-262015a7654e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70954-541-10 | 70954054110 | 100 TABLET in 1 BOTTLE, PLASTIC (70954-541-10) | 100 tablet | 2022-11-04 | 0000-00-00 | No | No | Current |