Naloxone Hydrochloride
- Product NDC
- 64725-1782
- 11-digit product format
- 647251782
- Labeler code
- 64725
- Product ID
- 64725-1782_4e92d5c6-3c12-4817-8ce9-c322dca29445
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALOXONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA070172
- Marketing category
- ANDA
- Marketing start
- 1986-09-24
- Marketing end
- 0000-00-00
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|
| 64725-1782-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e1b9-f424-e053-dadaa90a57ce | NALOXONE HYDROCHLORIDE INJECTION, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-1782-9 | Naloxone Hydrochloride | 10 mL in 1 BOX | INJECTION, SOLUTION | 10 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | ACTIVE INGREDIENT | F850569PQR | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| NALOXONE | ACTIVE MOIETY | 36B82AMQ7N | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-1782 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20141019_6a440ab0-f736-4ac3-a153-42c3fa65cd15.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191234 | naloxone HCl 0.4 MG in 1 ML Cartridge | PSN | 6a440ab0-f736-4ac3-a153-42c3fa65cd15 | 2 |
| 1191234 | 1 ML naloxone hydrochloride 0.4 MG/ML Cartridge | SCD | 6a440ab0-f736-4ac3-a153-42c3fa65cd15 | 2 |
| 1191234 | naloxone hydrochloride 0.4 MG per 1 ML Cartridge | SY | 6a440ab0-f736-4ac3-a153-42c3fa65cd15 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 64725-1782-9 | 64725178209 | 10 mL in 1 BOX | 10 ml | Historical |