Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 63629-8844
- 11-digit product format
- 636298844
- Labeler code
- 63629
- Product ID
- 63629-8844_3cbca028-fffd-43f8-87da-ac303bd88564
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Dosage form
- SUSPENSION
- Route
- AURICULAR (OTIC)
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA062488
- Marketing category
- ANDA
- Marketing start
- 2003-03-17
- 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 |
|---|
| 63629-8844-1 | 63629884401 | 10 mL in 1 BOTTLE, PLASTIC (63629-8844-1) | 10 ml | 2021-09-10 | No | No | Historical |