Betamethasone Sodium Phosphate and Betamethasone Acetate
- Product NDC
- 76420-007
- 11-digit product format
- 764200007
- Labeler code
- 76420
- Product ID
- 76420-007_ead06a22-6d5a-f9bb-e053-2a95a90aa12a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Sodium Phosphate and Betamethasone Acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA090747
- Marketing category
- ANDA
- Marketing start
- 2010-04-28
- 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 |
|---|
| 76420-007-05 | Betamethasone Sodium Phosphate and Betamethasone Acetate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-007 | BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTION, SUSPENSION [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20221013_c0a09d83-2405-450b-9f35-803d12823213.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 |
|---|
| 76420-007-05 | 76420000705 | 5 mL in 1 VIAL, MULTI-DOSE (76420-007-05) | 5 ml | 2020-01-16 | 0000-00-00 | No | No | Current |