Diphenhydramine
- Product NDC
- 65219-820
- 11-digit product format
- 652190820
- Labeler code
- 65219
- Product ID
- 65219-820_f4f0c26b-dad0-47a1-a9e7-6558c11254c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040466
- Marketing category
- ANDA
- Marketing start
- 2025-05-05
- 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 |
|---|
| 65219-820-00 | Diphenhydramine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 65219-820-01 | Diphenhydramine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-820 | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20250522_f4f0c26b-dad0-47a1-a9e7-6558c11254c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-820-00 | 65219082000 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 65219-820-01 | 65219082001 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-820-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-820-00) | | 2025-05-05 | No | No | Current |