Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 53002-9060
- 11-digit product format
- 530029060
- Labeler code
- 53002
- Product ID
- 53002-9060_21bad580-49e3-4a6e-b7e6-2ca193d2b332
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA062423
- Marketing category
- ANDA
- Marketing start
- 2003-03-18
- Marketing end
- 0000-00-00
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
- Active strength
- 4 mg/mL; [iU]/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [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 |
|---|
| 53002-9060-1 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-9060 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_2b1b7fdf-bbcf-47dc-9e27-5ddf0e14ba83.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 |
|---|
| 53002-9060-1 | 53002906001 | 10 mL in 1 BOTTLE (53002-9060-1) | 10 ml | 2017-10-01 | 0000-00-00 | No | No | Current |