Diphenhydramine
- Product NDC
- 83634-781
- 11-digit product format
- 836340781
- Labeler code
- 83634
- Product ID
- 83634-781_908025cf-e126-4241-b794-47d2fd90078e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Avenacy, LLC
- Application
- ANDA205336
- Marketing category
- ANDA
- Marketing start
- 2025-09-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenhydramine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1723740 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83634-781-01 | Diphenhydramine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
| 83634-781-41 | Diphenhydramine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-781-01 | 83634078101 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-781-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-781-41) | | 2025-09-01 | No | No | Current |
| 83634-781-41 | 83634078141 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |