Protherix
- Product NDC
- 70529-048
- 11-digit product format
- 705290048
- Labeler code
- 70529
- Product ID
- 70529-048_7e290c71-cfd5-4f73-bee9-576839b4af3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Triamcinolone Acetonide
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRAMUSCULAR
- Labeler
- IT3 Medical LLC
- Application
- ANDA207550
- Marketing category
- ANDA
- Marketing start
- 2018-09-01
- Marketing end
- 0000-00-00
- Substance
- TRIAMCINOLONE ACETONIDE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70529-048-01 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-02 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-03 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-01 | 2022-03-01 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-02 | 2022-03-01 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-03 | 2022-03-01 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
| 70529-048-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3593-a426-e053-dadaa90af4c2 | Protherix Injection System NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70529-048-01 | Protherix | 1 in 1 PACKAGE | INJECTION, SUSPENSION | 1 | | 2 |
| 70529-048-01 | Protherix | 1 mL in 1 VIAL | INJECTION, SUSPENSION | 1 | | 2 |
| 70529-048-02 | Protherix | 2 in 1 PACKAGE | INJECTION, SUSPENSION | 2 | | 2 |
| 70529-048-02 | Protherix | 1 mL in 1 VIAL | INJECTION, SUSPENSION | 1 | | 2 |
| 70529-048-03 | Protherix | 1 mL in 1 VIAL | INJECTION, SUSPENSION | 1 | | 2 |
| 70529-048-03 | Protherix | 3 in 1 PACKAGE | INJECTION, SUSPENSION | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70529-048 | PROTHERIX (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [IT3 MEDICAL LLC] | 2 | Legacy NDC, 6 package rows | 20220302_da9376f8-0133-46e4-af09-b84d43a829d1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70529-048-01 | 70529004801 | 1 VIAL in 1 PACKAGE (70529-048-01) > 1 mL in 1 VIAL | 1 vial | 2018-09-01 | 0000-00-00 | No | No | Current |
| 70529-048-02 | 70529004802 | 2 VIAL in 1 PACKAGE (70529-048-02) > 1 mL in 1 VIAL | 2 vial | 2018-09-01 | 0000-00-00 | No | No | Current |
| 70529-048-03 | 70529004803 | 3 VIAL in 1 PACKAGE (70529-048-03) > 1 mL in 1 VIAL | 3 vial | 2018-09-01 | 0000-00-00 | No | No | Current |