neomycin sulfate, polymyxin b sulfate and dexamethasone
- Product NDC
- 69918-515
- 11-digit product format
- 699180515
- Labeler code
- 69918
- Product ID
- 69918-515_2b581a09-38d8-4bd7-8b0a-17fa460b90f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and dexamethasone
- Dosage form
- SUSPENSION
- Route
- OPHTHALMIC
- Labeler
- Nordic Pharma, Inc.
- Application
- NDA050023
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-03-31
- Substance
- DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 1; 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 sulfate, polymyxin b sulfate and dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/mL |
| NEOMYCIN SULFATE | 3.5 mg/mL |
| POLYMYXIN B SULFATE | 10000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, 057Y626693, 19371312D4 |
| Rxcui | 309680 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69918-515-05 | neomycin sulfate, polymyxin b sulfate and dexamethasone | 5 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69918-515 | NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION [NORDIC PHARMA, INC.] | 1 | Current NDC, 1 package rows | 20250331_191c1a56-194f-4876-b501-2f8aee447d83.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69918-515-05 | 69918051505 | 5 mL in 1 BOTTLE, PLASTIC (69918-515-05) | 5 ml | 2025-03-31 | No | No | Current |