Polymyxin B Sulfate and Trimethoprim
- Product NDC
- 53002-8621
- 11-digit product format
- 530028621
- Labeler code
- 53002
- Product ID
- 53002-8621_334a7d54-bb53-465e-a119-aa88b04d40a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate and Trimethoprim
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA064211
- Marketing category
- ANDA
- Marketing start
- 1998-04-16
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ce811b5-329e-27f8-b5ff-66d52b435c00 | Product name | 3 | 20240108 |
| 8d30c4f0-0228-cea4-e3aa-f19064c47f27 | Product name | 3 | 20221128 |
| 6e20c430-5e8f-85da-1b03-f7dbc0c51fad | Product name | 3 | 20190926 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| c1381fd7-868a-f499-ef90-8f6d3e3ee6b3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-8621-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-cc43-f424-e053-dadaa90a57ce | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 53002-8621-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-cc43-f424-e053-dadaa90a57ce | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 53002-8621-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-cc43-f424-e053-dadaa90a57ce | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 53002-8621-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-cc43-f424-e053-dadaa90a57ce | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 53002-8621-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cc43-f424-e053-dadaa90a57ce | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-8621-1 | Polymyxin B Sulfate and Trimethoprim | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-8621 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_76e1be2e-eb19-48d4-9bfb-88537de839ba.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 244967 | polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution | PSN | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution | SCD | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution | SY | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution | SY | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution | SY | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-8621-1 | 53002862101 | 10 mL in 1 BOTTLE, DROPPER (53002-8621-1) | 10 ml | 2018-10-01 | 0000-00-00 | No | No | Current |