Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 63187-568
- 11-digit product format
- 631870568
- Labeler code
- 63187
- Product ID
- 63187-568_211667a9-4988-4c45-8678-c6ff4c1d4320
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Proficient Rx LP
- Application
- ANDA062423
- Marketing category
- ANDA
- Marketing start
- 2003-03-18
- Substance
- HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 10; 3.5; 10000 mg/mL; mg/mL; [iU]/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 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ, 057Y626693, 19371312D4 |
| Rxcui | 204423 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-568-10 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-568 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SOLUTION [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 1 package rows | 20220904_f5ef71ae-fca9-4a57-ae88-f2b2d195a179.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 |
|---|
| 63187-568-10 | 63187056810 | 10 mL in 1 BOTTLE (63187-568-10) | 10 ml | 2018-12-01 | 0000-00-00 | No | No | Current |