Diphenhydramine Hydrochloride
- Product NDC
- 72485-101
- 11-digit product format
- 724850101
- Labeler code
- 72485
- Product ID
- 72485-101_d949ac61-1864-4cf8-9b51-738b29952cc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA205723
- Marketing category
- ANDA
- Marketing start
- 2019-05-01
- 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 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 |
|---|
| 72485-101-01 | Diphenhydramine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 72485-101-05 | Diphenhydramine Hydrochloride | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 4 |
| 72485-101-25 | Diphenhydramine Hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-101 | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20230801_c1cd6138-ca31-4bb5-ae47-2d80d4d54f9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72485-101-01 | 72485010101 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 72485-101-05 | 72485010105 | 5 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-05) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01) | | 2023-05-05 | | No | No | Historical |
| 72485-101-25 | 72485010125 | 25 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01) | | 2019-05-01 | 0000-00-00 | No | No | Current |