Application 016636
- Type
- NDA
- Sponsor
- ADAPT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NARCAN | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | NARCAN | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | NARCAN | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016636-001 | NARCAN | NALOXONE HYDROCHLORIDE | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N016636-002 | NARCAN | NALOXONE HYDROCHLORIDE | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N016636-003 | NARCAN | NALOXONE HYDROCHLORIDE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 |
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UTC | 2026-02 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016636-002 | NARCAN | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016636-003 | NARCAN | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-06-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N016636-001 | NARCAN | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Sportpharm LLC | 3750bf77-342c-4469-8bbb-f71009aa03fa | 2026-07-02 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 53ed164c-dd09-4ea4-e063-6294a90a2434 | 2026-06-11 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 5906381c-81f4-4635-867a-e56e4d629692 | 2026-06-03 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Hospira, Inc. | 8535cc84-ad4a-4d67-8480-fb5a2e3406f8 | 2026-05-27 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Somerset Therapeutics, LLC | dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | 2026-05-05 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Sportpharm LLC | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2026-04-24 | Warnings | NARCAN |
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Emergent Devices Inc. | a0ebc83d-2892-40de-bc0a-775ce90b30db | 2026-04-22 | Warnings | NARCAN |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | BluePoint Laboratories | 327004b0-560a-84d0-e063-6294a90aa743 | 2026-04-02 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co. LLC. DBA HealthFirst | 4d66b96a-acbb-2292-e063-6294a90af788 | 2026-03-19 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Henry Schein, Inc | bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc | 2026-03-02 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | REMEDYREPACK INC. | 68df290c-d776-4cfc-9565-332eb56c4723 | 2026-02-10 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Lifestar Pharma LLC | aef6719c-cd71-46ee-b7b1-1806b939bf3e | 2026-02-09 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | AvKARE | 1766a7f1-d301-945f-e063-6294a90ac6f4 | 2026-01-14 | Warnings | NALOXONE HYDROCHLORIDE |
| RiVive | NALOXONE HYDROCHLORIDE | Harm Reduction Therapeutics, Inc. | 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d | 2026-01-13 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Sina Health Inc | 2879294f-9af9-459e-e063-6394a90a0820 | 2026-01-12 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | b5d40220-f194-4835-b70c-f304ecb222d5 | 2026-01-06 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | BPI Labs LLC | 5de44ee7-6525-4857-9a67-8882e96dbeb5 | 2025-12-26 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 8091a73d-9ecd-4578-a57b-5d85a2c5a16a | 2025-12-09 | Warnings | NALOXONE HYDROCHLORIDE |
| Narcan | NALOXONE HYDROCHLORIDE | Emergent Devices Inc. | 724df050-5332-4d0a-9a5f-17bf08a547e1 | 2025-12-05 | Warnings, Adverse reactions | Narcan NALOXONE HYDROCHLORIDE |
| ZIMHI | NALOXONE HYDROCHLORIDE | ZMI Pharma Inc. | 523c0909-bff6-4010-988a-53de18b7cb3f | 2025-12-04 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |