NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
- Product NDC
- 80425-0229
- 11-digit product format
- 804250229
- Labeler code
- 80425
- Product ID
- 80425-0229_2a9b1617-60d0-f8ce-e063-6294a90ab02c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA064063
- Marketing category
- ANDA
- Marketing start
- 2023-01-11
- 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
- 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 [USP'U]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL, 057Y626693, 19371312D4 |
| Rxcui | 309679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0229-1 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 80425-0229-1 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0229 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250102_f1a05d5f-74f2-17a1-e053-2995a90ab0e7.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 |
|---|
| 80425-0229-1 | 80425022901 | 1 TUBE in 1 CARTON (80425-0229-1) / 3.5 g in 1 TUBE | 1 tube | 2023-01-11 | 0000-00-00 | No | No | Current |