DIPHENHYDRAMINE
- Product NDC
- 42571-169
- 11-digit product format
- 425710169
- Labeler code
- 42571
- Product ID
- 42571-169_4c46492b-00c4-8ee4-e063-6294a90a6914
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Micro Labs Limited
- Application
- ANDA205723
- Marketing category
- ANDA
- Marketing start
- 2018-12-04
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DIPHENHYDRAMINE
- Listing expiration
- 2027-12-31
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 |
|---|
| 42571-169-54 | DIPHENHYDRAMINE | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 11 |
| 42571-169-55 | DIPHENHYDRAMINE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-169 | DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [MICRO LABS LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20221129_a1110433-498a-48cb-ac79-5732fd4f8fba.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 |
|---|
| 42571-169-54 | 42571016954 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 42571-169-55 | 42571016955 | 10 AMPULE in 1 CARTON (42571-169-55) / 1 mL in 1 AMPULE (42571-169-54) | 10 ampule | 2018-12-04 | 0000-00-00 | No | No | Current |