Polymyxin B Sulfate and Trimethoprim
- Product NDC
- 63187-834
- 11-digit product format
- 631870834
- Labeler code
- 63187
- Product ID
- 63187-834_0ccbd919-79d8-4159-9b3e-c31230c157db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate and Trimethoprim
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Proficient Rx LP
- Application
- ANDA064211
- Marketing category
- ANDA
- Marketing start
- 1998-04-16
- Substance
- POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
- Active strength
- 10000; 1 [USP'U]/mL; mg/mL
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Polymyxin B Sulfate and Trimethoprim
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYMYXIN B SULFATE | 10000 [USP'U]/mL |
| TRIMETHOPRIM SULFATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19371312D4, E377MF8EQ8 |
| Rxcui | 244967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-834-10 | Polymyxin B Sulfate and Trimethoprim | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-834 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 1 package rows | 20220426_1252b997-3a81-4f3c-90e4-92f29ba15713.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 |
|---|
| 63187-834-10 | 63187083410 | 10 mL in 1 BOTTLE, PLASTIC (63187-834-10) | 10 ml | 2018-12-01 | 0000-00-00 | No | No | Current |