Dexamethasone Sodium Phosphate
- Product NDC
- 68083-473
- 11-digit product format
- 680830473
- Labeler code
- 68083
- Product ID
- 68083-473_0ca8b553-e90b-4049-8c44-35b876d8f186
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexamethasone Sodium Phosphate
- Dosage form
- INJECTION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
- Labeler
- Gland Pharma Limited
- Application
- ANDA215654
- Marketing category
- ANDA
- Marketing start
- 2021-08-04
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexamethasone Sodium Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE SODIUM PHOSPHATE | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AI9376Y64P |
| Rxcui | 1116927, 1812079, 1812194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-473-01 | Dexamethasone Sodium Phosphate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 7 |
| 68083-473-25 | Dexamethasone Sodium Phosphate | 25 in 1 CARTON | INJECTION | 25 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-473 | DEXAMETHASONE SODIUM PHOSPHATE INJECTION [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240705_c9d9ab76-6bc6-433d-aad7-8d49064ed745.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 |
|---|
| 68083-473-01 | 68083047301 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 68083-473-25 | 68083047325 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-473-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-473-01) | | 2021-08-04 | 0000-00-00 | No | No | Current |