Neomycin and Polymyxin B Sulfates and Dexamethasone
- Product NDC
- 53002-9511
- 11-digit product format
- 530029511
- Labeler code
- 53002
- Product ID
- 53002-9511_25a83218-8794-47fd-b375-b9a62f9943f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and dexamethasone
- Dosage form
- SUSPENSION
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA062341
- Marketing category
- ANDA
- Marketing start
- 1996-02-21
- Marketing end
- 0000-00-00
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
- Active strength
- 4 mg/mL; [USP'U]/mL; mg/mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
- 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 |
|---|
| 53002-9511-1 | Neomycin and Polymyxin B Sulfates and Dexamethasone | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-9511 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 1 package rows | 20230609_2db509a5-4fb6-4053-938b-c7eb89623ead.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 |
|---|
| 53002-9511-1 | 53002951101 | 5 mL in 1 BOTTLE, DROPPER (53002-9511-1) | 5 ml | 2019-06-01 | 0000-00-00 | No | No | Current |