Neomycin and Polymyxin B Sulfates and Dexamethasone
- Product NDC
- 68071-2428
- 11-digit product format
- 680712428
- Labeler code
- 68071
- Product ID
- 68071-2428_48ea7ebd-a055-cbd4-e063-6394a90a77d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA064063
- Marketing category
- ANDA
- Marketing start
- 1994-07-25
- Substance
- DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 1; 3.5; 10000 mg/g; mg/g; [USP'U]/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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neomycin and Polymyxin B Sulfates and Dexamethasone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | 1 mg/g |
| NEOMYCIN SULFATE | 3.5 mg/g |
| POLYMYXIN B SULFATE | 10000 [USP'U]/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 |
|---|
| 68071-2428-3 | Neomycin and Polymyxin B Sulfates and Dexamethasone | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 2 |
| 68071-2428-3 | Neomycin and Polymyxin B Sulfates and Dexamethasone | 1 in 1 CARTON | OINTMENT | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2428 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210602_c3b6004a-8cfc-d5f8-e053-2a95a90a3efb.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 |
|---|
| 68071-2428-3 | 68071242803 | 1 TUBE in 1 CARTON (68071-2428-3) / 3.5 g in 1 TUBE | 1 tube | 2021-06-01 | 0000-00-00 | No | No | Current |