Trimethoprim
- Product NDC
- 43386-330
- 11-digit product format
- 433860330
- Labeler code
- 43386
- Product ID
- 43386-330_6a57562b-424f-40ef-9b86-fa0e66c1c344
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA091437
- Marketing category
- ANDA
- Marketing start
- 2011-06-24
- 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 |
|---|
| 43386-330-01 | Trimethoprim | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TRIMETHOPRIM | ACTIVE INGREDIENT | AN164J8Y0X | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TRIMETHOPRIM | ACTIVE MOIETY | AN164J8Y0X | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-330 | TRIMETHOPRIM TABLET [LUPIN PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241204_249e938d-f181-47c4-a082-372d65462f33.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 |
|---|
| 43386-330-01 | 43386033001 | 100 TABLET in 1 BOTTLE (43386-330-01) | 100 tablet | 2011-06-24 | 0000-00-00 | No | No | Current |