Betamethasone Sodium Phosphate and Betamethasone Acetate
- Product NDC
- 0517-0791
- 11-digit product format
- 005170791
- Labeler code
- 0517
- Product ID
- 0517-0791_0be90d39-6559-4241-b8be-c1ee438be718
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Sodium Phosphate and Betamethasone Acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR
- Labeler
- American Regent, Inc.
- Application
- ANDA090747
- Marketing category
- ANDA
- Marketing start
- 2019-11-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Betamethasone Sodium Phosphate and Betamethasone Acetate
- Listing expiration
- 2026-12-31
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-0791-01 | Betamethasone Sodium Phosphate and Betamethasone Acetate | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 3 |
| 0517-0791-01 | Betamethasone Sodium Phosphate and Betamethasone Acetate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0791 | BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTION, SUSPENSION [AMERICAN REGENT, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221203_335f17e7-069d-456c-8507-26253692f2ee.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0517-0791-01 | 00517079101 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0791-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2019-11-01 | 0000-00-00 | No | No | Current |