Neomycin and Polymyxin B Sulfates and Dexamethasone
- Product NDC
- 68071-3359
- 11-digit product format
- 680713359
- Labeler code
- 68071
- Product ID
- 68071-3359_1ce915c3-50fd-c89b-e063-6294a90a1d0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and dexamethasone
- Dosage form
- SUSPENSION
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA062341
- Marketing category
- ANDA
- Marketing start
- 1996-02-21
- 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 and Polymyxin B Sulfates 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3359-5 | Neomycin and Polymyxin B Sulfates and Dexamethasone | 5 mL in 1 BOX | SUSPENSION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3359 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240711_54da7bef-c3b0-4353-e054-00144ff8d46c.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 |
|---|
| 68071-3359-5 | 68071335905 | 5 mL in 1 BOX (68071-3359-5) | 5 ml | 2017-07-21 | No | No | Current |