Diphenhydramine
- Product NDC
- 63323-664
- 11-digit product format
- 633230664
- Labeler code
- 63323
- Product ID
- 63323-664_38e8f892-3aa1-473f-9906-8b7ee5d23e89
- 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
- 2002-08-01
- 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 |
|---|
| 63323-664-00 | Diphenhydramine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 6 |
| 63323-664-01 | Diphenhydramine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 6 |
| 63323-664-16 | Diphenhydramine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 4 |
| 63323-664-41 | Diphenhydramine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| diphenhydramine hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-664 | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250302_fc574e74-1fdc-4a61-a1ed-492ae43faed2.zip |
| 63323-664 | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241019_921b9f64-1096-46db-866a-67f0f9ff6790.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 |
|---|
| 63323-664-00 | 63323066400 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 63323-664-01 | 63323066401 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-664-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-664-00) | | 2002-08-01 | 0000-00-00 | No | No | Current |
| 63323-664-16 | 63323066416 | 25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41) | 25 vial | 2002-08-01 | 0000-00-00 | No | No | Current |
| 63323-664-41 | 63323066441 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |