CELESTONE SOLUSPAN
- Product NDC
- 85766-070
- 11-digit product format
- 857660070
- Labeler code
- 85766
- Product ID
- 85766-070_502f3a8b-e971-c921-e063-6294a90ae933
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Acetate and Betamethasone Sodium Phosphate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
- Labeler
- Sportpharm LLC
- Application
- NDA014602
- Marketing category
- NDA
- Marketing start
- 2021-06-01
- Substance
- BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
- Active strength
- 3; 3 mg/mL; mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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
- CELESTONE SOLUSPAN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETAMETHASONE ACETATE | 3 mg/mL |
| BETAMETHASONE SODIUM PHOSPHATE | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TI05AO53L7, 7BK02SCL3W |
| Rxcui | 578803, 578806 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-070-05 | CELESTONE SOLUSPAN | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 2 |
| 85766-070-05 | CELESTONE SOLUSPAN | 1 in 1 BOX | INJECTION, SUSPENSION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-070-05 | 85766007005 | 1 VIAL, MULTI-DOSE in 1 BOX (85766-070-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2025-10-01 | No | No | Historical |