Naloxone Hydrochloride
- Product NDC
- 50090-5427
- 11-digit product format
- 500905427
- Labeler code
- 50090
- Product ID
- 50090-5427_97b6bb78-800b-489f-bcae-ebcd3f6df0cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- ANDA207633
- Marketing category
- ANDA
- Marketing start
- 2017-08-08
- Marketing end
- 0000-00-00
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naloxone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5427-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-f993-0266-e053-dadaa90a7c1a | Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only |
| 50090-5427-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-f993-0266-e053-dadaa90a7c1a | Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only |
| 50090-5427-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f993-0266-e053-dadaa90a7c1a | Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only |
| 50090-5427-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f993-0266-e053-dadaa90a7c1a | Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5427 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC | 20241215_5906381c-81f4-4635-867a-e56e4d629692.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5427-0 | 50090542700 | 10 VIAL in 1 CARTON (50090-5427-0) > 1 mL in 1 VIAL | 10 vial | 2021-01-08 | 0000-00-00 | No | No | Current |