Diphenhydramine Hydrochloride
- Product NDC
- 76045-235
- 11-digit product format
- 760450235
- Labeler code
- 76045
- Product ID
- 76045-235_5bfd2f08-2d90-47b1-9677-73c503e66956
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA091526
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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 |
|---|
| 76045-235-10 | 76045023510 | 24 BLISTER PACK in 1 CARTON (76045-235-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-235-01) / 1 mL in 1 SYRINGE, GLASS | 24 blister pack | 2025-06-02 | No | No | Historical |