Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 63187-270
- 11-digit product format
- 631870270
- Labeler code
- 63187
- Product ID
- 63187-270_b775e7f3-60ea-4b65-a4a7-d196d391036f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Proficient Rx LP
- Application
- ANDA064053
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- 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 | 204423 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-270-10 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 63187-270-10 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| CUPRIC SULFATE | INACTIVE INGREDIENT | LRX7AJ16DT | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| POTASSIUM METABISULFITE | INACTIVE INGREDIENT | 65OE787Q7W | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-270 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 2 package rows | 20210116_d55f1783-9c49-4f90-9ff8-6f132e7b325e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-270-10 | 63187027010 | 1 BOTTLE, DROPPER in 1 CARTON (63187-270-10) / 10 mL in 1 BOTTLE, DROPPER | 2015-02-02 | 0000-00-00 | No | No | Current |