Diphenhydramine Hydrochloride
- Product NDC
- 76045-102
- 11-digit product format
- 760450102
- Labeler code
- 76045
- Product ID
- 76045-102_5bfd2f08-2d90-47b1-9677-73c503e66956
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA091526
- Marketing category
- ANDA
- Marketing start
- 2013-03-26
- 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 | 1049289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76045-102-00 | Diphenhydramine Hydrochloride | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 13 |
| 76045-102-00 | Diphenhydramine Hydrochloride | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 13 |
| 76045-102-10 | Diphenhydramine Hydrochloride | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76045-102 | DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230513_6d1aa0e2-036d-4382-a458-fc0300dba7cb.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 |
|---|
| 76045-102-00 | 76045010200 | 1 mL in 1 SYRINGE, GLASS | 1 ml | | | | | Historical |
| 76045-102-10 | 76045010210 | 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-102-00) / 1 mL in 1 SYRINGE, GLASS | 24 blister pack | 2013-03-26 | 0000-00-00 | No | No | Current |