Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 21695-437
- 11-digit product format
- 216950437
- Labeler code
- 21695
- Product ID
- 21695-437_5d57a327-4bdf-4aaa-88f3-e6754665f330
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Rebel Distributors Corp
- Application
- ANDA064053
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- Marketing end
- 0000-00-00
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
- Active strength
- 4 mg/mL; [USP'U]/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 21695-437-10 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 21695-437-10 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 1 |
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 [REBEL DISTRIBUTORS CORP] | 1 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| CUPRIC SULFATE | INACTIVE INGREDIENT | LRX7AJ16DT | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| POTASSIUM METABISULFITE | INACTIVE INGREDIENT | 65OE787Q7W | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-437 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20110210_5d57a327-4bdf-4aaa-88f3-e6754665f330.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-437-10 | 21695043710 | 1 in 1 CARTON | Historical |