epinephrine
- Product NDC
- 70385-2017
- 11-digit product format
- 703852017
- Labeler code
- 70385
- Product ID
- 70385-2017_8117ec68-5752-e83b-e053-2a91aa0a9bf2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Sina Health Inc
- Application
- NDA020800
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2010-04-01
- Marketing end
- 0000-00-00
- Substance
- EPINEPHRINE
- Active strength
- 0 mg/.15mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 70385-2017-1 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2824-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR. Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939 |
| 70385-2017-1 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2824-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR. Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939 |
| 70385-2017-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2824-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR. Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70385-2017-1 | epinephrine | 1 in 1 CASE | INJECTION | 1 | | 2 |
| 70385-2017-1 | epinephrine | 1 in 1 BAG | INJECTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70385-2017 | EPINEPHRINE INJECTION [SINA HEALTH INC] | 2 | Legacy NDC, 2 package rows | 20190205_4cc59056-a5ae-696d-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 70385-2017-1 | 70385201701 | 1 in 1 CASE | Historical |