Polymyxin B Sulfate and Trimethoprim
- Product NDC
- 53217-305
- 11-digit product format
- 532170305
- Labeler code
- 53217
- Product ID
- 53217-305_08a728cf-c494-47e8-b725-a6d8632bcbcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate and Trimethoprim
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA064211
- Marketing category
- ANDA
- Marketing start
- 2017-04-27
- Marketing end
- 0000-00-00
- Substance
- POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
- Active strength
- 10000 [USP'U]/mL; mg/mL
- Pharmacologic classes
- Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-305-01 | Polymyxin B Sulfate and Trimethoprim | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-305 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 2 | Legacy NDC, 1 package rows | 20180524_12de69e0-e8de-4871-833b-30cc4a0a6965.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 53217-305-01 | 53217030501 | 10 mL in 1 BOTTLE, PLASTIC | 10 ml | Historical |