NPD
- Product NDC
- 57319-307
- 11-digit product format
- 573190307
- Labeler code
- 57319
- Product ID
- 57319-307_2a1d77e9-c706-4d9b-9745-e93ef4919c8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Phoenix Pharmaceutical, Inc.
- Application
- ANDA064063
- Marketing category
- ANDA
- Marketing start
- 1994-07-25
- Marketing end
- 0000-00-00
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
- Active strength
- 4 mg/g; [USP'U]/g; mg/g
- 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 |
|---|
| 57319-307-25 | NPD | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
| 57319-307-25 | NPD | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXAMETHASONE | ACTIVE INGREDIENT | 7S5I7G3JQL | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| DEXAMETHASONE | ACTIVE MOIETY | 7S5I7G3JQL | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57319-307 | NPD (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [PHOENIX PHARMACEUTICAL, INC.] | 1 | Legacy NDC, 2 package rows | 20101208_2a1d77e9-c706-4d9b-9745-e93ef4919c8a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 57319-307-25 | 57319030725 | 1 in 1 CARTON | Historical |