Naloxone Hydrochloride
- Product NDC
- 0641-6205
- 11-digit product format
- 006416205
- Labeler code
- 0641
- Product ID
- 0641-6205_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
- 2022-06-10
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 1 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 table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1191250, 2679504 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6205-01 | Naloxone Hydrochloride | 2 mL in 1 SYRINGE | INJECTION | 2 | | 7 |
| 0641-6205-10 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6205 | NALOXONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240411_e6467385-6990-498c-8a0e-f4a40ef33cb7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-6205-01 | 00641620501 | 2 mL in 1 SYRINGE | 2 ml | | | | | Historical |
| 0641-6205-10 | 00641620510 | 10 SYRINGE in 1 CARTON (0641-6205-10) / 2 mL in 1 SYRINGE (0641-6205-01) | 10 syringe | 2022-06-10 | 0000-00-00 | No | No | Current |