Polymyxin B Sulfate and Trimethoprim
- Product NDC
- 53002-8620
- 11-digit product format
- 530028620
- Labeler code
- 53002
- Product ID
- 53002-8620_4090e44c-7278-469c-8587-6e269bdcd06d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate and Trimethoprim Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA064120
- Marketing category
- ANDA
- Marketing start
- 1997-02-14
- 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
- 2021-12-31
- 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 |
|---|
| 53002-8620-1 | Polymyxin B Sulfate and Trimethoprim | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8620 | POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_565bc07b-01fd-4931-8c9e-a07e901a3f8a.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 |
|---|
| 53002-8620-1 | 53002862001 | 10 mL in 1 BOTTLE, DROPPER (53002-8620-1) | 10 ml | 2017-10-01 | 0000-00-00 | No | No | Current |