NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Product NDC
- 60219-2084
- 11-digit product format
- 602192084
- Labeler code
- 60219
- Product ID
- 60219-2084_22c9a9e5-2701-4f12-90a5-97ebf87c62b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Dosage form
- SUSPENSION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA217735
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/mL |
| NEOMYCIN SULFATE | 3.5 mg/mL |
| POLYMYXIN B SULFATE | 10000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ, 057Y626693, 19371312D4 |
| Rxcui | 310687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-2084-6 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 4 |
| 60219-2084-6 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 10 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 10 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-2084-6 | 60219208406 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-2084-6) / 10 mL in 1 BOTTLE, PLASTIC | 2025-09-30 | No | No | Current |