Naloxone Hydrochloride
- Product NDC
- 70069-071
- 11-digit product format
- 700690071
- Labeler code
- 70069
- Product ID
- 70069-071_c30c2699-564b-4c18-89ec-36dfd7df3bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA207633
- Marketing category
- ANDA
- Marketing start
- 2017-08-08
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207633-001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207633-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A207633-001 | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE / INJECTION | AP | 2017-08-08 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207633-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207633-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207633-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207633-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207633-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207633-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207633-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207633-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207633-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207633-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207633-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207633-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207633-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207633-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207633-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207633-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207633-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207633-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207633-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207633-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207633-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207633-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207633-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207633-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207633-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207633-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207633-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207633-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207633-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207633-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207633-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207633-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207633-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207633-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207633-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207633-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207633-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207633-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A207633-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A207633-001 | AP | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naloxone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NALOXONE HYDROCHLORIDE | .4 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F850569PQR | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1659929 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70069-071-01 | Naloxone Hydrochloride | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | 10 | |
| 70069-071-10 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70069-071-01 | ML - Milliliter | 70069-071 | 5bb0bc0a-9443-4813-888a-4da0adfc4b5d | 1 | 2017-09-11 |
| 70069-071-10 | ML - Milliliter | 70069-071 | d363e647-352f-4318-a663-46a1ff1867a0 | 1 | 2017-09-11 |
DailyMed Dashboard NDC Coverage#
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 | A-S Medication Solutions | 5906381c-81f4-4635-867a-e56e4d629692 | 2026-06-03 | Warnings, Adverse reactions | 207633 ANDA207633 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Somerset Therapeutics, LLC | dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | 2026-05-05 | Warnings, Adverse reactions | 207633 ANDA207633 70069-071 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Sina Health Inc | 2879294f-9af9-459e-e063-6394a90a0820 | 2026-01-12 | Warnings, Adverse reactions | 207633 ANDA207633 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | ProPharma Distribution | 3856ea66-29b8-8fc2-e063-6394a90ac33a | 2025-07-18 | Warnings, Adverse reactions | 207633 ANDA207633 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e53f169-4a6e-6102-e053-2995a90ab3dc | 2023-05-09 | Warnings, Adverse reactions | 207633 ANDA207633 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1659929 | naloxone HCl 0.4 MG in 1 ML Injection | PSN | 2879294f-9af9-459e-e063-6394a90a0820 | 11 |
| 1659929 | 1 ML naloxone hydrochloride 0.4 MG/ML Injection | SCD | 2879294f-9af9-459e-e063-6394a90a0820 | 11 |
| 1659929 | naloxone HCl 0.4 MG per 1 ML Injection | SY | 2879294f-9af9-459e-e063-6394a90a0820 | 11 |
| 1659929 | naloxone HCl 0.4 MG in 1 ML Injection | PSN | dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | 10 |
| 1659929 | 1 ML naloxone hydrochloride 0.4 MG/ML Injection | SCD | dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | 10 |
| 1659929 | naloxone HCl 0.4 MG per 1 ML Injection | SY | dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | 10 |
| 1659929 | naloxone HCl 0.4 MG in 1 ML Injection | PSN | 10c22ce2-7dbe-4417-b8b4-602b190b1ddd | 5 |
| 1659929 | naloxone HCl 0.4 MG in 1 ML Injection | PSN | 9e53f169-4a6e-6102-e053-2995a90ab3dc | 5 |
| 1659929 | 1 ML naloxone hydrochloride 0.4 MG/ML Injection | SCD | 10c22ce2-7dbe-4417-b8b4-602b190b1ddd | 5 |
| 1659929 | 1 ML naloxone hydrochloride 0.4 MG/ML Injection | SCD | 9e53f169-4a6e-6102-e053-2995a90ab3dc | 5 |
| 1659929 | naloxone HCl 0.4 MG per 1 ML Injection | SY | 10c22ce2-7dbe-4417-b8b4-602b190b1ddd | 5 |
| 1659929 | naloxone HCl 0.4 MG per 1 ML Injection | SY | 9e53f169-4a6e-6102-e053-2995a90ab3dc | 5 |
| 1659929 | naloxone HCl 0.4 MG in 1 ML Injection | PSN | 3856ea66-29b8-8fc2-e063-6394a90ac33a | 3 |
| 1659929 | 1 ML naloxone hydrochloride 0.4 MG/ML Injection | SCD | 3856ea66-29b8-8fc2-e063-6394a90ac33a | 3 |
| 1659929 | naloxone HCl 0.4 MG per 1 ML Injection | SY | 3856ea66-29b8-8fc2-e063-6394a90ac33a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70069-071-01 | 70069007101 | 1 mL in 1 VIAL | 1 ml | Historical | ||||
| 70069-071-10 | 70069007110 | 10 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01) | 10 vial | 2017-08-08 | 0000-00-00 | No | No | Current |