epinephrine
- Product NDC
- 0115-1694
- 11-digit product format
- 001151694
- Labeler code
- 0115
- Product ID
- 0115-1694_fdafd090-bed3-4f16-8ab1-fd1573aa633e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- NDA020800
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2010-04-01
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020800-001 | TWINJECT | EPINEPHRINE | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | ||
| N020800-002 | TWINJECT | EPINEPHRINE | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | ||
| N020800-003 | ADRENACLICK | EPINEPHRINE | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 |
| N020800-004 | ADRENACLICK | EPINEPHRINE | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020800-003 | BX |
| N020800-004 | BX |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020800-001 | TWINJECT | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020800-002 | TWINJECT | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020800-001 | TWINJECT | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020800-002 | TWINJECT | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020800-001 | TWINJECT | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020800-002 | TWINJECT | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020800-001 | TWINJECT 0.3 | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2003-05-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020800-002 | TWINJECT 0.15 | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | 2004-05-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020800-003 | ADRENACLICK | EQ 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020800-004 | ADRENACLICK | EQ 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | BX | RLD, RS | 2009-11-25 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020800-003 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020800-004 | BX | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020800-003 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020800-004 | BX | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020800-003 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020800-004 | BX | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020800-003 | BX | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020800-004 | BX | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020800-003 | BX | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020800-004 | BX | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020800-003 | BX | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020800-004 | BX | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020800-003 | BX | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020800-004 | BX | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020800-003 | BX | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020800-004 | BX | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020800-003 | BX | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020800-004 | BX | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020800-003 | BX | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020800-004 | BX | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020800-003 | BX | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020800-004 | BX | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020800-003 | BX | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020800-004 | BX | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020800-003 | BX | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020800-004 | BX | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020800-003 | BX | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020800-004 | BX | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-003 | BX | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-004 | BX | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020800-003 | BX | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020800-004 | BX | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020800-003 | BX | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020800-004 | BX | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020800-003 | BX | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020800-004 | BX | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020800-003 | BX | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020800-004 | BX | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020800-003 | BX | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020800-004 | BX | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-001 | 7297136 | 2025-01-18 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-001 | 7621891 | 2025-02-04 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-002 | 7297136 | 2025-01-18 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-002 | 7621891 | 2025-02-04 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-003 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-003 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-004 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020800-004 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020800-001 | 7297136 | 2025-01-18 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020800-001 | 7621891 | 2025-02-04 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020800-002 | 7297136 | 2025-01-18 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020800-002 | 7621891 | 2025-02-04 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020800-003 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020800-003 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020800-004 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020800-004 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020800-001 | 7297136 | 2025-01-18 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020800-001 | 7621891 | 2025-02-04 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020800-002 | 7297136 | 2025-01-18 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020800-002 | 7621891 | 2025-02-04 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020800-003 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020800-003 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020800-004 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020800-004 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020800-001 | 7297136 | 2025-01-18 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020800-001 | 7621891 | 2025-02-04 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020800-002 | 7297136 | 2025-01-18 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020800-002 | 7621891 | 2025-02-04 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020800-003 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020800-004 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020800-001 | 7297136 | 2025-01-18 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020800-001 | 7621891 | 2025-02-04 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020800-002 | 7297136 | 2025-01-18 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020800-002 | 7621891 | 2025-02-04 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020800-003 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020800-003 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020800-004 | 10166334 | 2025-01-21 | Drug product | 2020-02-11 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020800-004 | 7905352 | 2027-04-12 | Drug product | 2017-06-02 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020800-001 | 7297136 | 2025-01-18 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020800-001 | 7621891 | 2025-02-04 | Drug product | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- epinephrine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| EPINEPHRINE | .3 mg/.3mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| YKH834O4BH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0115-1694-30 | epinephrine | 1 in 1 CARTON | INJECTION | 1 | 16 | |
| 0115-1694-30 | epinephrine | 1 in 1 CASE | INJECTION | 1 | 16 | |
| 0115-1694-49 | epinephrine | 2 in 1 CARTON | INJECTION | 2 | 16 | |
| 0115-1694-49 | epinephrine | 1 in 1 CASE | INJECTION | 1 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0115-1694-30 | EA - Each | 0115-1694 | d7a54aa3-12ed-470a-9854-11cd94591357 | 1 | 2019-06-19 |
| 0115-1694-49 | EA - Each | 0115-1694 | 8f59b63e-d9a0-4426-8607-bce9aae464a2 | 1 | 2017-03-06 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| epinephrine | EPINEPHRINE | REMEDYREPACK INC. | c66de0d3-3b0f-4e52-a712-60357a107676 | 2026-03-24 | Warnings, Adverse reactions | 020800 NDA020800 |
| epinephrine | EPINEPHRINE | Amneal Pharmaceuticals of New York LLC | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 2026-03-20 | Warnings, Adverse reactions | 020800 NDA020800 0115-1694 |
| epinephrine | EPINEPHRINE | REMEDYREPACK INC. | bfc7ab3d-1e0e-4fd9-b6df-09603eb5808c | 2026-02-18 | Warnings, Adverse reactions | 020800 NDA020800 |
| epinephrine | EPINEPHRINE | Sportpharm LLC | e7798493-9407-4a5d-9c90-0cc336c59ec1 | 2026-02-03 | Warnings, Adverse reactions | 020800 NDA020800 |
| Epinephrine Pediatrics | EPINEPHRINE 0.15 PEDIATRICS | Sina Health Inc | 287930f8-c5c6-56bd-e063-6394a90ad32e | 2026-01-12 | Warnings, Adverse reactions | 020800 NDA020800 |
| Epinephrine 0.3 Adults | EPINEPHRINE 0.3 ADULTS | Sina Health Inc | 28642ad9-b839-ce3a-e063-6394a90ab866 | 2026-01-12 | Warnings, Adverse reactions | 020800 NDA020800 |
| epinephrine | EPINEPHRINE | A-S Medication Solutions | a5134e63-9a31-4573-826f-b442d069b3e6 | 2025-11-19 | Warnings, Adverse reactions | 020800 NDA020800 |
| epinephrine | EPINEPHRINE | ASCLEMED USA INC. | 76f65a94-4b26-4c40-8a74-79a73afbb4e2 | 2025-09-04 | Warnings, Adverse reactions | 020800 NDA020800 |
| Epinephrine | EPINEPHRINE | Advanced Rx Pharmacy of Tennessee, LLC | f4d7aca4-0acd-74c2-e053-2995a90a9d94 | 2024-12-31 | Warnings, Adverse reactions | 020800 NDA020800 |
| epinephrine | EPINEPHRINE | Asclemed USA, Inc. | 0a29fe62-e241-4272-b91c-c1036b031cd4 | 2024-08-02 | Warnings, Adverse reactions | 020800 NDA020800 |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 2022-12-09 | Warnings, Adverse reactions | 020800 NDA020800 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1870225 | EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-Injector | PSN | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 16 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 16 |
| 1870225 | NDA020800 0.15 ML epinephrine 1 MG/ML Auto-Injector | SCD | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 16 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 16 |
| 1870225 | epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-Injector | SY | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 16 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | e13f05f1-7d21-49bb-b8d5-24bf9301c3d7 | 16 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | 28642ad9-b839-ce3a-e063-6394a90ab866 | 15 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | 28642ad9-b839-ce3a-e063-6394a90ab866 | 15 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | 28642ad9-b839-ce3a-e063-6394a90ab866 | 15 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | a5134e63-9a31-4573-826f-b442d069b3e6 | 13 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | c66de0d3-3b0f-4e52-a712-60357a107676 | 13 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | a5134e63-9a31-4573-826f-b442d069b3e6 | 13 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | c66de0d3-3b0f-4e52-a712-60357a107676 | 13 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | a5134e63-9a31-4573-826f-b442d069b3e6 | 13 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | c66de0d3-3b0f-4e52-a712-60357a107676 | 13 |
| 1870225 | EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-Injector | PSN | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 7 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 7 |
| 1870225 | NDA020800 0.15 ML epinephrine 1 MG/ML Auto-Injector | SCD | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 7 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 7 |
| 1870225 | epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-Injector | SY | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 7 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | 75dbc3f5-9caf-9f55-e053-2a91aa0a4719 | 7 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 212033 | aspirin 325 MG Oral Tablet | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 211874 | BAYER Aspirin 325 MG Oral Tablet | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049633 | diphenhydrAMINE HCl 50 MG/ML Injectable Solution | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1870225 | EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-Injector | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 310519 | glucose 4 GM Chewable Tablet | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | PSN | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 211874 | aspirin 325 MG Oral Tablet [Bayer Aspirin] | SBD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 212033 | aspirin 325 MG Oral Tablet | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049633 | diphenhydramine hydrochloride 50 MG/ML Injectable Solution | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 310519 | glucose 4000 MG Chewable Tablet | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1870225 | NDA020800 0.15 ML epinephrine 1 MG/ML Auto-Injector | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | SCD | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 212033 | ASA 325 MG Oral Tablet | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 211874 | ASA 325 MG Oral Tablet [Bayer Aspirin] | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 211874 | Bayer Aspirin 325 MG Oral Tablet | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049633 | diphenhydramine HCl 50 MG/ML Injectable Solution | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1870225 | epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-Injector | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 310519 | glucose 4 GM Chewable Tablet | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 198039 | nitroglycerin 400 MCG Sublingual Tablet | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 198039 | NTG 0.4 MG Sublingual Tablet | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 198039 | TNG 0.4 MG Sublingual Tablet | SY | bae7a52f-504b-416e-afdd-e6853e2d5944 | 5 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 212033 | aspirin 325 MG Oral Tablet | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 211874 | BAYER Aspirin 325 MG Oral Tablet | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1049633 | diphenhydrAMINE HCl 50 MG/ML Injectable Solution | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 310519 | glucose 4 GM Chewable Tablet | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | PSN | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 211874 | aspirin 325 MG Oral Tablet [Bayer Aspirin] | SBD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 212033 | aspirin 325 MG Oral Tablet | SCD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1049633 | diphenhydramine hydrochloride 50 MG/ML Injectable Solution | SCD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 310519 | glucose 4000 MG Chewable Tablet | SCD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 2123111 | NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler | SCD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1870230 | NDA020800 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | SCD | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 2123111 | albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 212033 | ASA 325 MG Oral Tablet | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 211874 | ASA 325 MG Oral Tablet [Bayer Aspirin] | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 211874 | Bayer Aspirin 325 MG Oral Tablet | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1049633 | diphenhydramine HCl 50 MG/ML Injectable Solution | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1870230 | epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-Injector | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 310519 | glucose 4 GM Chewable Tablet | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 198039 | nitroglycerin 400 MCG Sublingual Tablet | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 198039 | NTG 0.4 MG Sublingual Tablet | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 198039 | TNG 0.4 MG Sublingual Tablet | SY | 58d78805-3e8c-4859-b2e0-e3089f925280 | 4 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | f4d7aca4-0acd-74c2-e053-2995a90a9d94 | 2 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | 677bcf31-c1e0-4d82-e053-2991aa0ac2ff | 2 |
| 1870230 | EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-Injector | PSN | e7798493-9407-4a5d-9c90-0cc336c59ec1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0115-1694-30 | 00115169430 | 1 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS | 1 case | 2010-04-01 | 0000-00-00 | No | No | Current |
| 0115-1694-49 | 00115169449 | 2 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS | 2 case | 2010-04-01 | 0000-00-00 | No | No | Current |