Dexamethasone Sodium Phosphate
- Product NDC
- 67457-418
- 11-digit product format
- 674570418
- Labeler code
- 67457
- Product ID
- 67457-418_178a2eca-55c3-4ce9-8388-05a6469f120e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone Sodium Phosphate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
- Labeler
- Mylan Institutional LLC
- Application
- ANDA040803
- Marketing category
- ANDA
- Marketing start
- 2020-04-15
- Marketing end
- 2026-10-31
- Substance
- DEXAMETHASONE SODIUM PHOSPHATE
- Active strength
- 4 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexamethasone Sodium Phosphate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE SODIUM PHOSPHATE | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AI9376Y64P |
| Rxcui | 309696, 1116927, 1812194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-418-00 | Dexamethasone Sodium Phosphate | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 6 |
| 67457-418-05 | Dexamethasone Sodium Phosphate | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXAMETHASONE SODIUM PHOSPHATE | ACTIVE INGREDIENT | AI9376Y64P | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| DEXAMETHASONE | ACTIVE MOIETY | 7S5I7G3JQL | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-418 | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20200702_836f8017-d023-410b-8515-ec776e73ca59.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 |
|---|
| 67457-418-00 | 67457041800 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 67457-418-05 | 67457041805 | 25 VIAL in 1 CARTON (67457-418-05) / 5 mL in 1 VIAL (67457-418-00) | 25 vial | 2020-04-15 | 2026-10-31 | No | No | Current |