Diphenhydramine Hydrochloride
- Product NDC
- 0404-9851
- 11-digit product format
- 004049851
- Labeler code
- 0404
- Product ID
- 0404-9851_6bcc631f-5945-4ce5-912d-9fb3403e3670
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA080817
- Marketing category
- ANDA
- Marketing start
- 2022-01-17
- 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 |
|---|
| 0404-9851-01 | Diphenhydramine Hydrochloride | 1 in 1 BAG | INJECTION | 1 | | 5 |
| 0404-9851-01 | Diphenhydramine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9851 | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240828_af972e71-62ab-40c6-925a-cbcb4d6720a4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9851-01 | 00404985101 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9851-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-01-17 | 0000-00-00 | No | No | Current |