Dexamethasone Sodium Phosphate
- Product NDC
- 0404-9795
- 11-digit product format
- 004049795
- Labeler code
- 0404
- Product ID
- 0404-9795_224e880f-7c59-4576-b113-3fafde2b6602
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone Sodium Phosphate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
- Labeler
- Henry Schein, Inc.
- Application
- ANDA040803
- Marketing category
- ANDA
- Marketing start
- 2025-02-06
- Substance
- DEXAMETHASONE SODIUM PHOSPHATE
- Active strength
- 4 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexamethasone Sodium Phosphate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE SODIUM PHOSPHATE | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AI9376Y64P |
| Rxcui | 1116927 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9795-30 | Dexamethasone Sodium Phosphate | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 3 |
| 0404-9795-30 | Dexamethasone Sodium Phosphate | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9795 | DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 2 | Current NDC, 2 package rows | 20250223_c464ffde-f64e-4716-92d2-720a10793248.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9795-30 | 00404979530 | 1 VIAL in 1 BAG (0404-9795-30) / 30 mL in 1 VIAL | 1 vial | 2025-02-06 | No | No | Current |