epinephrine
- Product NDC
- 42291-425
- 11-digit product format
- 422910425
- Labeler code
- 42291
- Product ID
- 42291-425_ec6b210b-e84b-d325-e053-2a95a90a3e93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- AvKARE
- Application
- NDA020800
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-12-07
- Marketing end
- 0000-00-00
- Substance
- EPINEPHRINE
- Active strength
- 0 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 42291-425 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 42291-425 | 42291-425-02 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42291-425-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42291-425-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42291-425-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42291-425-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42291-425-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42291-425-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42291-425-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42291-425-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42291-425-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42291-425-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42291-425-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42291-425-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-425-02 | EA - Each | 42291-425 | 7b841d9e-ae23-48b7-90d4-4c7e11d0bd1b | 1 | 2021-01-08 |
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-425-02 | 42291042502 | 2 SYRINGE, GLASS in 1 CARTON (42291-425-02) > .3 mL in 1 SYRINGE, GLASS | 2020-12-07 | 0000-00-00 | No | No | Current |