Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 63187-648
- 11-digit product format
- 631870648
- Labeler code
- 63187
- Product ID
- 63187-648_a0c2530c-4783-482e-9630-10eba7412c01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Dosage form
- SUSPENSION
- Route
- AURICULAR (OTIC)
- Labeler
- Proficient Rx LP
- Application
- ANDA062488
- Marketing category
- ANDA
- Marketing start
- 2003-03-17
- Substance
- HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 10; 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 Hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/mL |
| NEOMYCIN SULFATE | 3.5 mg/mL |
| POLYMYXIN B SULFATE | 10000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ, 057Y626693, 19371312D4 |
| Rxcui | 310687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-648-10 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 10 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-648 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 1 package rows | 20220512_601cab21-c211-4c34-be7b-f4fdd97a921a.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 |
|---|
| 63187-648-10 | 63187064810 | 10 mL in 1 BOTTLE, PLASTIC (63187-648-10) | 10 ml | 2018-12-01 | 0000-00-00 | No | No | Current |