Neomycin and Polymyxin B Sulfates
- Product NDC
- 39822-1201
- 11-digit product format
- 398221201
- Labeler code
- 39822
- Product ID
- 39822-1201_4d508cf6-f6a4-be9f-e063-6394a90af91e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin and Polymyxin B Sulfates
- Dosage form
- SOLUTION
- Route
- IRRIGATION
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA065106
- Marketing category
- ANDA
- Marketing start
- 2006-01-19
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 40; 200000 mg/mL; [USP'U]/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neomycin and Polymyxin B Sulfates
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NEOMYCIN SULFATE | 40 mg/mL |
| POLYMYXIN B SULFATE | 200000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19371312D4, 057Y626693 |
| Rxcui | 314124 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-1201-1 | Neomycin and Polymyxin B Sulfates | 1 mL in 1 AMPULE | SOLUTION | 1 | | 18 |
| 39822-1201-2 | Neomycin and Polymyxin B Sulfates | 10 in 1 CARTON | SOLUTION | 10 | | 18 |
| 39822-1201-5 | Neomycin and Polymyxin B Sulfates | 50 in 1 CARTON | SOLUTION | 50 | | 18 |
| 39822-1201-5 | Neomycin and Polymyxin B Sulfates | 1 mL in 1 AMPULE | SOLUTION | 1 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-1201 | NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20231219_a2f47d77-efd3-4c84-a364-08fb6d9978eb.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 |
|---|
| 39822-1201-1 | 39822120101 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 39822-1201-2 | 39822120102 | 10 AMPULE in 1 CARTON (39822-1201-2) > 1 mL in 1 AMPULE (39822-1201-1) | 10 ampule | 2006-01-19 | 0000-00-00 | No | No | Current |
| 39822-1201-5 | 39822120105 | 50 AMPULE in 1 CARTON (39822-1201-5) / 1 mL in 1 AMPULE | 50 ampule | 2006-01-19 | 0000-00-00 | No | No | Current |