Neomycin and Polymyxin B Sulfates and Dexamethasone
- Product NDC
- 68071-5281
- 11-digit product format
- 680715281
- Labeler code
- 68071
- Product ID
- 68071-5281_2a80353b-e221-492b-e063-6294a90a3a7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin and Polymyxin B Sulfates and Dexamethasone
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- NDA050065
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1996-02-21
- Substance
- DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 1; 3.5; 10000 mg/g; mg/g; [iU]/g
- 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 Dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/g |
| NEOMYCIN SULFATE | 3.5 mg/g |
| POLYMYXIN B SULFATE | 10000 [iU]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, 057Y626693, 19371312D4 |
| Rxcui | 309679 |
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 |
|---|
| 68071-5281-3 | Neomycin and Polymyxin B Sulfates and Dexamethasone | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5281 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250101_a7e55c43-4345-4710-e053-2995a90aeee7.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 |
|---|
| 68071-5281-3 | 68071528103 | 3.5 g in 1 TUBE (68071-5281-3) | 3.5 g | 2020-06-12 | 0000-00-00 | No | No | Current |