Naloxone Hydrochloride
- Product NDC
- 0641-6193
- 11-digit product format
- 006416193
- Labeler code
- 0641
- Product ID
- 0641-6193_2f3fbff5-628a-49f6-9867-06c876742876
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA212300
- Marketing category
- ANDA
- Marketing start
- 2025-07-25
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naloxone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NALOXONE HYDROCHLORIDE | .4 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F850569PQR |
| Rxcui | 1191250, 2679504 |
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 |
|---|---|---|---|---|---|---|
| 0641-6193-01 | Naloxone Hydrochloride | 1 mL in 1 SYRINGE | INJECTION | 1 | 7 | |
| 0641-6193-10 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6193-01 | ML - Milliliter | 0641-6193 | d8d0b59a-cacf-4759-a725-0044e570daa9 | 1 | 2025-09-12 |
| 0641-6193-10 | ML - Milliliter | 0641-6193 | 88f68b6e-f2ee-4cf5-91ce-bd54086ca5ba | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191250 | naloxone HCl 2 MG in 2 ML Prefilled Syringe | PSN | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 7 |
| 2679504 | naloxone hydrochloride 0.4 MG in 1 ML Prefilled Syringe | PSN | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 7 |
| 2679504 | 1 ML naloxone hydrochloride 0.4 MG/ML Prefilled Syringe | SCD | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 7 |
| 1191250 | 2 ML naloxone hydrochloride 1 MG/ML Prefilled Syringe | SCD | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 7 |
| 2679504 | naloxone hydrochloride 0.4 MG per 1 ML Prefilled Syringe | SY | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 7 |
| 1191250 | naloxone hydrochloride 2 MG per 2 ML Prefilled Syringe | SY | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0641-6193-01 | 00641619301 | 1 mL in 1 SYRINGE | 1 ml | Historical | |||
| 0641-6193-10 | 00641619310 | 10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01) | 10 syringe | 2025-08-31 | No | No | Historical |