POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE
- Product NDC
- 52959-609
- 11-digit product format
- 529590609
- Labeler code
- 52959
- Product ID
- 52959-609_998080ce-a00c-4518-92fd-a985679ad681
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polymyxin B sulfate, trimethoprim sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA050567
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1997-04-29
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 52959-609-10 | POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
| 52959-609-10 | POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| polymyxin B sulfate | ACTIVE INGREDIENT | 19371312D4 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| trimethoprim sulfate | ACTIVE INGREDIENT | E377MF8EQ8 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| polymyxin B | ACTIVE MOIETY | J2VZ07J96K | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| trimethoprim | ACTIVE MOIETY | AN164J8Y0X | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| sulfuric acid | INACTIVE INGREDIENT | O40UQP6WCF | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-609 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 2 | Legacy NDC, 2 package rows | 20120104_0461401a-17c1-460f-b9ec-ff1cfe514f57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-609-10 | 52959060910 | 1 in 1 CARTON | Historical |