NARCAN
- Product NDC
- 85766-076
- 11-digit product format
- 857660076
- Labeler code
- 85766
- Product ID
- 85766-076_50317ec7-5f58-b35a-e063-6394a90a7303
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- naloxone hydrochloride nasal
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Sportpharm LLC
- Application
- NDA208411
- Marketing category
- NDA
- Marketing start
- 2023-08-28
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 4 mg/.1mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NARCAN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NALOXONE HYDROCHLORIDE | 4 mg/.1mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F850569PQR |
| Rxcui | 1725059, 1725064 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85766-076-02 | NARCAN | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | 2 | |
| 85766-076-02 | NARCAN | 2 in 1 CARTON | SPRAY | 2 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1725059 | naloxone HCl 4 MG in 0.1 ML Nasal Spray | PSN | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2 |
| 1725064 | NARCAN 4 MG in 0.1 ML Nasal Spray | PSN | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2 |
| 1725064 | naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan] | SBD | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2 |
| 1725059 | naloxone hydrochloride 40 MG/ML Nasal Spray | SCD | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2 |
| 1725059 | naloxone HCl 4 MG per 0.1 ML Nasal Spray | SY | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2 |
| 1725064 | Narcan 40 MG/ML Nasal Spray | SY | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-076-02 | 85766007602 | 2 VIAL, SINGLE-DOSE in 1 CARTON (85766-076-02) / .1 mL in 1 VIAL, SINGLE-DOSE | 2025-10-10 | No | No | Historical |