CELESTONE SOLUSPAN
- Product NDC
- 78206-118
- 11-digit product format
- 782060118
- Labeler code
- 78206
- Product ID
- 78206-118_1086d646-36dd-465c-ab6d-fc4e3b51115b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Acetate and Betamethasone Sodium Phosphate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
- Labeler
- Organon 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 |
|---|---|
| BETAMETHASONE ACETATE | 3 mg/mL |
| BETAMETHASONE SODIUM PHOSPHATE | 3 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | TI05AO53L7, 7BK02SCL3W |
| Rxcui | 578803, 578806 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dde7b902-54a1-627e-12f1-9e6d244ab88c | Product name | 4 | 20250317 |
| 69b49899-11cf-4f7e-bd0a-7dc93b27311b | Product name | 3 | 20250130 |
| bbdc14c7-d940-43b5-a2f7-36c425991f3c | Product name | 1 | 20240320 |
| 0a2fcc35-464b-9ec2-a622-753662cdd48c | Product name | 3 | 20240216 |
| 6f762601-17ef-4321-8f47-77783d3c4d8b | Product name | 3 | 20231116 |
| 1dbefad7-ab34-69c3-e51a-e7148aa38f70 | Product name | 5 | 20220921 |
| 7fea2046-07a9-4bb6-9409-828ac6f1f6df | Product name | 1 | 20210201 |
| f059f1a2-0e64-4839-9a7f-42687c91a44b | Product name | 1 | 20201007 |
| 4ea9e4b5-b452-48ad-9b25-b9a4d403405d | Product name | 1 | 20160310 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 4f07db9b-3707-3e2c-05b5-d7852ba808c4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78206-118-01 | CELESTONE SOLUSPAN | 1 in 1 BOX | INJECTION, SUSPENSION | 1 | 10 | |
| 78206-118-01 | CELESTONE SOLUSPAN | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 78206-118-01 | ML - Milliliter | 78206-118 | bc027590-521a-4ced-90f2-a8d63b111861 | 1 | 2021-09-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 78206-118 | CELESTONE SOLUSPAN (BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE) INJECTION, SUSPENSION [ORGANON LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250112_bf78d1be-42d7-4837-92a5-49113a79278f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 578803 | betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable Suspension | PSN | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578806 | Celestone Soluspan 6 MG/ML Injectable Suspension | PSN | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578806 | betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension [Celestone Soluspan] | SBD | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578803 | betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension | SCD | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578803 | betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable Suspension | SY | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578806 | Celestone 6 MG/ML Injectable Suspension | SY | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578806 | Celestone Soluspan (betamethasone (as betamethasone sodium phosphate) 3 MG / betamethasone acetate 3 MG) per ML Injectable Suspension | SY | bf78d1be-42d7-4837-92a5-49113a79278f | 10 |
| 578803 | betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable Suspension | PSN | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
| 578806 | Celestone Soluspan 6 MG/ML Injectable Suspension | PSN | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
| 578806 | betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension [Celestone Soluspan] | SBD | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
| 578803 | betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension | SCD | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
| 578803 | betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable Suspension | SY | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
| 578806 | Celestone 6 MG/ML Injectable Suspension | SY | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
| 578806 | Celestone Soluspan (betamethasone (as betamethasone sodium phosphate) 3 MG / betamethasone acetate 3 MG) per ML Injectable Suspension | SY | 95a19c2f-c329-4ce1-a0a7-174814aac3ad | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 78206-118-01 | 78206011801 | 1 VIAL, MULTI-DOSE in 1 BOX (78206-118-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2021-06-01 | 0000-00-00 | No | No | Current |