NALOXONE HYDROCHLORIDE
- Product NDC
- 63629-9321
- 11-digit product format
- 636299321
- Labeler code
- 63629
- Product ID
- 63629-9321_9c47fac5-40e9-43ae-b7d1-9a12ad1f8b3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211951
- Marketing category
- ANDA
- Marketing start
- 2022-06-21
- 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 product | product | 63629-9321 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 63629-9321 | 63629-9321-1 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211951-001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 |
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 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | AB | 2022-06-21 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211951-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2022-06-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211951-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211951-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A211951-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A211951-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211951-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A211951-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A211951-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211951-001 | AB | 1 | cb3db0bc1861… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-9321-1 | EA - Each | 63629-9321 | d34f9c30-9410-4e48-ac9d-1112077c18c1 | 1 | 2022-08-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-9321 | NALOXONE HYDROCHLORIDE SPRAY [BRYANT RANCH PREPACK] | 102 | Legacy NDC | 20240116_73edcc70-d988-4f66-a09a-8d23042283c3.zip |
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 | BluePoint Laboratories | 327004b0-560a-84d0-e063-6294a90aa743 | 2026-04-02 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | b5d40220-f194-4835-b70c-f304ecb222d5 | 2026-01-06 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Strategic Sourcing Services LLC | 577fbd57-7054-4536-86c1-d43bc99cc7b1 | 2025-11-19 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | AMERISOURCE BERGEN | cce38c13-0d2f-49bb-94fa-6f2bbb4d5984 | 2025-08-31 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Bryant Ranch Prepack | ed549649-dcbd-41f7-a774-876906751c5a | 2024-10-03 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 1be2e38b-55ca-abea-e063-6394a90ac548 | 2024-06-27 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 19b0603b-241f-f439-e063-6294a90ae85f | 2024-05-30 | Warnings | 211951 ANDA211951 |
| NALOXONE HCl | NALOXONE HCL | HF Acquisition Co LLC, DBA HealthFirst | f8fcda15-8ba6-e66a-e053-6294a90a385c | 2024-01-28 | Warnings, Adverse reactions | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 46f27d04-d4d2-4ef1-9cc5-4d58f4056f06 | 2023-12-27 | Warnings | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 0b3b5214-6f91-4bba-82d6-d57b16845df5 | 2023-10-01 | Warnings, Adverse reactions | 211951 ANDA211951 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Proficient Rx LP | 8d529b4c-85fd-4e50-9443-9080825307bf | 2022-10-01 | Warnings, Adverse reactions | 211951 ANDA211951 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-9321-1 | 63629932101 | 2 mL in 1 VIAL, SINGLE-DOSE (63629-9321-1) | 2 ml | 2022-07-07 | 0000-00-00 | No | No | Current |