Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 76420-104
- 11-digit product format
- 764200104
- Labeler code
- 76420
- Product ID
- 76420-104_b2ddcdd0-72c2-99df-e053-2a95a90a8818
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA064053
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- Substance
- HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WI4X0X7BPJ | HYDROCORTISONE | 50-23-7 | HYDROCORTISONE |
| 057Y626693 | NEOMYCIN SULFATE | 1405-10-3 | NEOMYCIN SULFATE |
| 19371312D4 | POLYMYXIN B SULFATE | 1405-20-5 | POLYMYXIN B SULFATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-104-10 | 76420010410 | 10 mL in 1 BOTTLE, DROPPER (76420-104-10) | 10 ml | 2020-10-30 | No | No | Historical |