EPINEPHRINE
- Product NDC
- 62250-102
- 11-digit product format
- 622500102
- Labeler code
- 62250
- Product ID
- 62250-102_3cfb1126-cf17-4f86-8568-653b3050e1b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EPINEPHRINE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Belcher Pharmaceuticals, LLC
- Application
- NDA205029
- Marketing category
- NDA
- Marketing start
- 2022-02-28
- Marketing end
- 0000-00-00
- Substance
- EPINEPHRINE
- Active strength
- 1 mg/mL
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0b4ec9ca-d305-43fc-88dd-7a510313efe0 | Product name | 1 | 20260105 |
| bb209f42-a85f-4fee-9d3d-c9dded168625 | Product name | 1 | 20251208 |
| 49628fc7-2031-4c28-bd31-0ef3aa8f44a3 | Product name | 3 | 20251118 |
| cbf85893-59ef-423f-87d4-a573c000a8b9 | Product name | 8 | 20250731 |
| b5b1095b-40cd-8a9e-b111-502545045b07 | Product name | 4 | 20250325 |
| e190029e-423b-473c-8e04-2ada59b5b711 | Product name | 1 | 20250314 |
| e0031c74-3853-42bc-8e10-86dbbe83992e | Product name | 2 | 20231116 |
| f7046b89-2016-499a-adc6-78479172abc6 | Product name | 1 | 20230425 |
| 2686d634-e712-4007-8dbf-3d37c6c4d71f | Product name | 1 | 20181121 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| bd49bb86-2d32-4a7a-a594-eeda2e29af42 | Product name | 1 | 20180118 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 3becbe78-12d9-4ad2-9b4c-1e36f8d1303a | Product name | 1 | 20170815 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62250-102-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-43fc-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP 10 mg/10 mL (1 mg/mL) Multiple Dose Vial, for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62250-102-01 | EPINEPHRINE | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 62250-102-01 | EPINEPHRINE | 10 mL in 1 VIAL | INJECTION | 10 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310132 | EPINEPHrine 1 MG/ML (1:1000) Injectable Solution | PSN | 6a8d8eb1-66aa-4195-9f98-8ebcc2e166d1 | 1 |
| 310132 | epinephrine 1 MG/ML Injectable Solution | SCD | 6a8d8eb1-66aa-4195-9f98-8ebcc2e166d1 | 1 |
| 310132 | epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution | SY | 6a8d8eb1-66aa-4195-9f98-8ebcc2e166d1 | 1 |
| 310132 | epinephrine 1:1000 Injectable Solution | SY | 6a8d8eb1-66aa-4195-9f98-8ebcc2e166d1 | 1 |
| 310132 | epinephrine 500 MCG per 0.5 ML Injectable Solution | SY | 6a8d8eb1-66aa-4195-9f98-8ebcc2e166d1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62250-102-01 | 62250010201 | 1 VIAL in 1 CARTON (62250-102-01) > 10 mL in 1 VIAL | 1 vial | 2022-02-28 | 0000-00-00 | No | No | Current |