EVZIO(R) NALOXONE HCl
- Product NDC
- 51662-1495
- Requested package NDC
- 51662-1495-1
- 11-digit product format
- 516621495
- Labeler code
- 51662
- Product ID
- 51662-1495_9f4536f0-d9de-3b36-e053-2a95a90ab8f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EVZIO(R) NALOXONE HCl
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- NDA209862
- Marketing category
- NDA
- Marketing start
- 2020-01-11
- Marketing end
- 0000-00-00
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 2 mg/.4mL
- Pharmacologic classes
- Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 51662-1495 | 51662-1495-1 | I | Inactivated by FDA | 2026-08-11 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209862-001 | EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209862-001 | 9278182 | 2026-02-01 | Drug product | 2016-11-07 | |
| N209862-001 | 8926594 | 2026-03-31 | Drug product | 2016-11-07 | |
| N209862-001 | 7731686 | 2026-06-01 | Drug product | 2016-11-07 | |
| N209862-001 | 10960155 | 2026-06-25 | Drug product | 2021-04-22 | |
| N209862-001 | 11590286 | 2026-12-12 | Drug product | 2023-03-29 | |
| N209862-001 | 9238108 | 2027-02-20 | Drug product | 2016-11-07 | |
| N209862-001 | 8206360 | 2027-02-27 | Drug product | 2016-11-07 | |
| N209862-001 | 9724471 | 2027-05-23 | U-2092 | Drug product | 2017-08-23 |
| N209862-001 | 7947017 | 2028-03-12 | Drug product | 2016-11-07 | |
| N209862-001 | 7749194 | 2028-10-30 | Drug product | 2016-11-07 | |
| N209862-001 | 8231573 | 2028-11-25 | Drug product | 2016-11-07 | |
| N209862-001 | 8226610 | 2029-04-10 | Drug product | 2016-11-07 | |
| N209862-001 | 8021344 | 2029-11-02 | Drug product | 2016-11-07 | |
| N209862-001 | 10322239 | 2031-02-28 | U-1907 | 2019-06-19 | |
| N209862-001 | 8939943 | 2031-02-28 | Drug product | 2016-11-07 | |
| N209862-001 | 9022022 | 2031-02-28 | Drug product | 2016-11-07 | |
| N209862-001 | 9474869 | 2031-02-28 | U-1907 | Drug product | 2016-11-07 |
| N209862-001 | 10143792 | 2031-05-24 | U-2476 | 2019-01-02 | |
| N209862-001 | 8627816 | 2032-02-04 | Drug product | 2016-11-07 | |
| N209862-001 | 9517307 | 2034-07-18 | U-1925 | Drug product | 2016-12-19 |
| N209862-001 | 10220158 | 2035-03-20 | U-2500 | Drug product | 2019-03-27 |
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 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9278182 | 2026-02-01 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8926594 | 2026-03-31 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 7731686 | 2026-06-01 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10960155 | 2026-06-25 | Drug product | 2021-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 11590286 | 2026-12-12 | Drug product | 2023-03-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9238108 | 2027-02-20 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8206360 | 2027-02-27 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9724471 | 2027-05-23 | U-2092 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 7947017 | 2028-03-12 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 7749194 | 2028-10-30 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8231573 | 2028-11-25 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8226610 | 2029-04-10 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8021344 | 2029-11-02 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10322239 | 2031-02-28 | U-1907 | 2019-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8939943 | 2031-02-28 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9022022 | 2031-02-28 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9474869 | 2031-02-28 | U-1907 | Drug product | 2016-11-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10143792 | 2031-05-24 | U-2476 | 2019-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8627816 | 2032-02-04 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9517307 | 2034-07-18 | U-1925 | Drug product | 2016-12-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10220158 | 2035-03-20 | U-2500 | Drug product | 2019-03-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7731690 | 2025-01-15 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8016788 | 2025-03-21 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 10335549 | 2025-04-30 | Drug product | 2019-07-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9278182 | 2026-02-01 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8926594 | 2026-03-31 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7731686 | 2026-06-01 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 10960155 | 2026-06-25 | Drug product | 2021-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 11590286 | 2026-12-12 | Drug product | 2023-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9238108 | 2027-02-20 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8206360 | 2027-02-27 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9724471 | 2027-05-23 | U-2092 | Drug product | 2017-08-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7947017 | 2028-03-12 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7749194 | 2028-10-30 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8231573 | 2028-11-25 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8226610 | 2029-04-10 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8021344 | 2029-11-02 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 10322239 | 2031-02-28 | U-1907 | 2019-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8939943 | 2031-02-28 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9022022 | 2031-02-28 | Drug product | 2016-11-07 | 31067a03dcf5… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c955d208-c333-9bd7-be34-d7e12986d44e | Product name | 6 | 20250626 |
| e5f98bfa-66d5-4c3a-b22d-9543d3bee304 | Product name | 1 | 20250204 |
| caa6391e-3db3-c912-335f-61b5fc00aa12 | Product name | 9 | 20240110 |
| 65a3bc34-04ff-4cf1-aad9-c7d92a062f6d | Product name | 1 | 20231003 |
| e951cdf3-f269-4d97-a7d5-c1c3d7283a7d | Product name | 3 | 20230313 |
| ab841ac7-728a-4fc9-be0a-35b96cecbf39 | Product name | 4 | 20230306 |
| f327b80c-8fa2-404b-838a-df3eec141cf2 | Product name | 1 | 20221212 |
| d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119 | Product name | 1 | 20220511 |
| b871fccd-1de6-4c7f-b9e5-045304641ee6 | Product name | 8 | 20220118 |
| 43b1efe2-1425-4b3e-b3a2-57d40f8478b9 | Product name | 1 | 20211026 |
| 4c23a34c-e8fc-424c-8fa0-ee064ba6eaef | Product name | 1 | 20170706 |
| 0b8c7273-1da3-495f-909a-7cf1e96d2361 | Product name | 1 | 20161212 |
| 3df867ed-9d48-45cf-bded-1394beaea0b1 | Product name | 3 | 20161206 |
| 8a245632-e24f-4ccc-b671-995d89c96ebc | Product name | 1 | 20141203 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51662-1495-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5f3b-d83d-e063-dadaa90ab31f | EVZIO(R) NALOXONE HCl INJECTION, USP 2mg AUTO-INJECTOR 2 PACK |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1495-1 | EVZIO(R) NALOXONE HCl | 0.4 mL in 1 DOSE PACK | INJECTION, SOLUTION | 0.4 | 2 | |
| 51662-1495-1 | EVZIO(R) NALOXONE HCl | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51662-1495 | EVZIO(R) NALOXONE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Legacy NDC, 2 package rows | 20200224_9be31bdf-e220-2978-e053-2a95a90a03c6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1855730 | naloxone HCl 2 MG in 0.4 ML Auto-Injector | PSN | 9be31bdf-e220-2978-e053-2a95a90a03c6 | 2 |
| 1855730 | 0.4 ML naloxone hydrochloride 5 MG/ML Auto-Injector | SCD | 9be31bdf-e220-2978-e053-2a95a90a03c6 | 2 |
| 1855730 | naloxone HCl 2 MG per 0.4 ML Auto-Injector | SY | 9be31bdf-e220-2978-e053-2a95a90a03c6 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51662-1495-1 | 51662149501 | 2 DOSE PACK in 1 CARTON (51662-1495-1) > .4 mL in 1 DOSE PACK | 2 dose pack | 2020-01-11 | 0000-00-00 | No | No | Current |