Naloxone Hydrochloride
- Product NDC
- 55700-985
- Requested package NDC
- 55700-985-01
- 11-digit product format
- 557000985
- Labeler code
- 55700
- Product ID
- 55700-985_358c3d1a-23cf-4e10-b79f-5b739f713aa9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride Nasal Spray
- Dosage form
- INHALANT
- Route
- NASAL
- Labeler
- Quality Care Products, LLC
- Application
- NDA208411
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-10-11
- Marketing end
- 0000-00-00
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 4 mg/.1mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- 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 package | package | 55700-985 | 55700-985-01 | D | Discontinued by firm | 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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-985 | 55700-985-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-985 | 55700-985-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208411-001 | NARCAN | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | |
| N208411-002 | NARCAN | NALOXONE HYDROCHLORIDE | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 |
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 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | RLD, RS | 2015-11-18 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | RLD, RS | 2015-11-18 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-002 | NARCAN | 2MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | RLD, RS | 2015-11-18 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208411-002 | NARCAN | 2MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208411-002 | NARCAN | 2MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | RLD, RS | 2015-11-18 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208411-001 | NARCAN | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2015-11-18 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208411-002 | NARCAN | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SPRAY, METERED / NASAL | RLD | 2017-01-24 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N208411-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N208411-001 | AB | 1 | bb7c543d1eb4… |
| 2023-01-26 05:58 UTC | 2023-01 | N208411-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N208411-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N208411-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N208411-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N208411-001 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-01-30 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product, Delist requested | 2017-07-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | 10085937 | 2035-03-16 | U-1903 | 2018-10-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | 9211253 | 2035-03-16 | Drug product | 2015-12-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | 9468747 | 2035-03-16 | U-1903 | Drug product | 2016-10-18 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | 9561177 | 2035-03-16 | U-1903 | Drug product | 2017-02-07 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | 9629965 | 2035-03-16 | U-1903 | Drug product | 2017-04-27 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-001 | 9775838 | 2035-03-16 | U-1903 | 2017-10-05 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product | 2017-01-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product | 2017-07-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | 10085937 | 2035-03-16 | U-1903 | 2018-10-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | 9211253 | 2035-03-16 | Drug product | 2015-12-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | 9468747 | 2035-03-16 | U-1903 | Drug product | 2016-10-18 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | 9561177 | 2035-03-16 | U-1903 | Drug product | 2017-02-07 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | 9629965 | 2035-03-16 | U-1903 | Drug product | 2017-04-27 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-001 | 9775838 | 2035-03-16 | U-1903 | 2017-10-05 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-002 | 9480644 | 2035-03-16 | U-1903 | Drug product | 2017-01-30 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208411-002 | 9707226 | 2035-03-16 | U-1903 | Drug product | 2017-07-18 | 5d02ea3f76ae… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-985-01 | EA - Each | 55700-985 | 0c73c798-9bb0-435f-9363-55708157fc92 | 1 | 2022-11-07 |
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 |
|---|---|---|---|---|---|---|
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Sportpharm LLC | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2026-04-24 | Warnings | 208411 NDA208411 |
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Emergent Devices Inc. | a0ebc83d-2892-40de-bc0a-775ce90b30db | 2026-04-22 | Warnings | 208411 NDA208411 |
| Narcan | NALOXONE HYDROCHLORIDE | Emergent Devices Inc. | 724df050-5332-4d0a-9a5f-17bf08a547e1 | 2025-12-05 | Warnings, Adverse reactions | 208411 NDA208411 |
| Narcan Naloxone HCL | NARCAN NALOXONE HCL | HF Acquisition Co LLC, DBA HealthFirst | 11d770b8-b768-ba3d-e063-6394a90a61a6 | 2024-02-20 | Warnings | 208411 NDA208411 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE NASAL | A-S Medication Solutions | 4517afa1-4b17-4a15-b91b-65b18bd0558f | 2023-11-24 | Warnings, Adverse reactions | 208411 NDA208411 |
| NARCAN NALOXONE HCI | NARCAN NALOXONE HCI | HF Acquisition Co LLC, DBA HealthFirst | 784a0e98-c2d6-f845-e053-2991aa0ac4b4 | 2023-10-10 | Warnings, Adverse reactions | 208411 NDA208411 |
| NARCAN | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 139c30b9-5600-48f5-8610-0cacd2782398 | 2023-09-28 | Warnings, Adverse reactions | 208411 NDA208411 |
| Narcan | NALOXONE HYDROCHLORIDE | Proficient Rx LP | 76b5a1ce-e601-457c-ab35-43533bba4394 | 2022-08-01 | Warnings, Adverse reactions | 208411 NDA208411 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-985-01 | 55700098501 | 2 VIAL, SINGLE-DOSE in 1 CARTON (55700-985-01) > .1 mL in 1 VIAL, SINGLE-DOSE | 2022-10-11 | 0000-00-00 | No | No | Current |