Diphenhydramine hydrochloride
- Product NDC
- 0641-6282
- 11-digit product format
- 006416282
- Labeler code
- 0641
- Product ID
- 0641-6282_1fddaa59-14d4-4339-8e9c-1c479499a4b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA080817
- Marketing category
- ANDA
- Marketing start
- 1972-11-27
- 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 hydrochloride
- 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 |
|---|
| 0641-6282-01 | Diphenhydramine hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 3 |
| 0641-6282-25 | Diphenhydramine hydrochloride | 25 in 1 PACKAGE | INJECTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6282 | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 3 | Current NDC, 2 package rows | 20250406_829bbcbf-fb27-4484-aff6-a7e7467670af.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 |
|---|
| 0641-6282-01 | 00641628201 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 0641-6282-25 | 00641628225 | 25 VIAL in 1 PACKAGE (0641-6282-25) / 1 mL in 1 VIAL (0641-6282-01) | 25 vial | 1972-11-27 | No | No | Historical |