Epinephrine
- Product NDC
- 50090-2734
- 11-digit product format
- 500902734
- Labeler code
- 50090
- Product ID
- 50090-2734_aaeb2e08-e729-48ef-a6a4-8d4a66cf2e6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epinephrine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- NDA019430
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-12-15
- Marketing end
- 0000-00-00
- Substance
- EPINEPHRINE
- Active strength
- 0 mg/.3mL
- 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
- E
- Listing certified through
- 2018-12-31
- 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 | 50090-2734 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 50090-2734 | 50090-2734-0 | I | Inactivated by FDA | 2026-08-03 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 50090-2734-0 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 50090-2734-0 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019430-001 | EPIPEN | EPINEPHRINE | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 |
| N019430-002 | EPIPEN JR. | EPINEPHRINE | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 |
| N019430-003 | EPIPEN E Z PEN | EPINEPHRINE | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | ||
| N019430-004 | EPI E Z PEN JR | EPINEPHRINE | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019430-001 | AB |
| N019430-002 | AB |
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 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019430-001 | EPIPEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019430-002 | EPIPEN JR. | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS | AB | RLD, RS | 1987-12-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019430-003 | EPIPEN E Z PEN | 0.3MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019430-004 | EPI E Z PEN JR | 0.15MG/DELIVERY | INJECTABLE / INTRAMUSCULAR | 1995-08-03 | 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 | N019430-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019430-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019430-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019430-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019430-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019430-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019430-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019430-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019430-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019430-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019430-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019430-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019430-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019430-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019430-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019430-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019430-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019430-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019430-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019430-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019430-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019430-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019430-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019430-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019430-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019430-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019430-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019430-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019430-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N019430-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019430-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N019430-002 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | 7449012 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | 7794432 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | 8048035 | 2025-09-11 | Drug product | 2011-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-001 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | 7449012 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | 7794432 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | 8048035 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019430-002 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | 7449012 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | 7794432 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | 8048035 | 2025-09-11 | Drug product | 2011-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-001 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | 7449012 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | 7794432 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | 8048035 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019430-002 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | 7449012 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | 7794432 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | 8048035 | 2025-09-11 | Drug product | 2011-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-001 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | 7449012 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | 7794432 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | 8048035 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019430-002 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | 7449012 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | 7794432 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | 8048035 | 2025-09-11 | Drug product | 2011-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-001 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | 7449012 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | 7794432 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | 8048035 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | 8870827 | 2025-09-11 | Drug product | 2014-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019430-002 | 9586010 | 2025-09-11 | Drug product | 2017-05-12 | b8a1b40f171c… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2734-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0576-f424-e053-dadaa90a57ce | 1aa23ef5-7c23-45a3-b25f-a822ca1e679f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2734-0 | EA - Each | 50090-2734 | dffcbc3d-42b2-4b3e-ab2b-186a01a2a672 | 1 | 2019-04-11 |
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 0.3 Adults | EPINEPHRINE 0.3 ADULTS | Sina Health Inc | 2865e9a5-1228-e2bc-e063-6394a90af94e | 2026-01-12 | Warnings, Adverse reactions | 019430 NDA019430 |
| Epinephrine 0.15 Pediatrics | EPINEPHRINE 0.15 PEDIATRICS | Sina Health Inc | 28649bcc-648c-c977-e063-6394a90a0b2b | 2026-01-12 | Warnings, Adverse reactions | 019430 NDA019430 |
| Epinephrine | EPINEPHRINE | A-S Medication Solutions | b7a4171c-7934-4723-a140-bd93ea84aae1 | 2023-11-21 | Warnings, Adverse reactions | 019430 NDA019430 |
| EPIPEN | EPINEPHRINE | Asclemed USA, Inc. | 311af6d9-20c0-4b87-b236-4185bfa49988 | 2023-08-29 | Warnings, Adverse reactions | 019430 NDA019430 |
| Epinephrine | EPINEPHRINE | Medical Purchasing Solutions, LLC | 6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab | 2023-05-22 | Warnings, Adverse reactions | 019430 NDA019430 |
| Epinephrine | EPINEPHRINE | Medical Purchasing Solutions, LLC | 6bdca08a-65bf-f56c-e053-2a91aa0a56d8 | 2023-05-22 | Warnings, Adverse reactions | 019430 NDA019430 |
| EPIPEN | EPINEPHRINE | Viatris Specialty LLC | 7560c201-9246-487c-a13b-6295db04274a | 2023-02-15 | Warnings, Adverse reactions | 019430 NDA019430 |
| Epinephrine | EPINEPHRINE | Viatris Specialty LLC | 778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836 | 2023-02-15 | Warnings, Adverse reactions | 019430 NDA019430 |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 75e96faa-545b-52d6-e053-2991aa0a8fb8 | 2022-12-09 | Warnings, Adverse reactions | 019430 NDA019430 |