Diphenhydramine Hydrochloride
- Product NDC
- 68083-611
- 11-digit product format
- 680830611
- Labeler code
- 68083
- Product ID
- 68083-611_89f09a33-2535-47c9-8942-dd8ebe5d3b4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218448
- Marketing category
- ANDA
- Marketing start
- 2024-03-20
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE | 147-24-0 | DIPHENHYDRAMINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-611-25 | 68083061125 | 25 VIAL in 1 CARTON (68083-611-25) / 1 mL in 1 VIAL | 25 vial | 2024-03-20 | No | No | Historical |