Epinephrine
- Product NDC
- 70518-2283
- 11-digit product format
- 705182283
- Labeler code
- 70518
- Product ID
- 70518-2283_49f0d87f-9010-9aa8-e063-6394a90aa3ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epinephrine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090589
- Marketing category
- ANDA
- Marketing start
- 2019-08-26
- Substance
- EPINEPHRINE
- Active strength
- .3 mg/.3mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Epinephrine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINEPHRINE | .3 mg/.3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YKH834O4BH |
| Rxcui | 1870207 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-2283-0 | 2023-03-09 | C162847 | 48780-1 | f386c649-f17b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use EPINEPHRINE INJECTION, 0.3 mg and EPINEPHRINE INJECTION, 0.15 mg safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, 0.3 mg and EPINEPHRINE INJECTION, 0.15 mg. EPINEPHRINE injection, 0.3 mg, for intramuscular or subcutaneous use EPINEPHRINE injection, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939 |
| 70518-2283-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f17b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use EPINEPHRINE INJECTION, 0.3 mg and EPINEPHRINE INJECTION, 0.15 mg safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, 0.3 mg and EPINEPHRINE INJECTION, 0.15 mg. EPINEPHRINE injection, 0.3 mg, for intramuscular or subcutaneous use EPINEPHRINE injection, 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 |
|---|
| 70518-2283-0 | Epinephrine | 2 in 1 CARTON | INJECTION | 2 | | 9 |
| 70518-2283-0 | Epinephrine | 1 in 1 CONTAINER | INJECTION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2283 | EPINEPHRINE INJECTION [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250510_de4916c5-bdc8-4da9-a857-a319882a831a.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 |
|---|
| 70518-2283-0 | 70518228300 | 2 CONTAINER in 1 CARTON (70518-2283-0) / 1 SYRINGE in 1 CONTAINER / .3 mL in 1 SYRINGE | 2 container | 2019-08-26 | 0000-00-00 | No | No | Current |