Naloxone Hydrochloride
- Product NDC
- 72572-450
- 11-digit product format
- 725720450
- Labeler code
- 72572
- Product ID
- 72572-450_9d4007b7-f036-40c2-bbbe-0176fc62f249
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nalxone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Civica, Inc.
- Application
- ANDA070299
- Marketing category
- ANDA
- Marketing start
- 2019-11-11
- 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 table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1191222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72572-450-01 | Naloxone Hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 4 |
| 72572-450-25 | Naloxone Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72572-450 | NALOXONE HYDROCHLORIDE (NALXONE HYDROCHLORIDE) INJECTION [CIVICA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241222_21d20dff-6efe-481e-a5a0-9c80ded73ca9.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 |
|---|
| 72572-450-01 | 72572045001 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 72572-450-25 | 72572045025 | 25 VIAL in 1 CARTON (72572-450-25) / 1 mL in 1 VIAL (72572-450-01) | 25 vial | 2019-11-11 | 0000-00-00 | No | No | Current |