Dimenhydrinate
- Product NDC
- 63323-366
- 11-digit product format
- 633230366
- Labeler code
- 63323
- Product ID
- 63323-366_b3e3433d-c18b-4ed3-b2ba-1e550474ca33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimenhydrinate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040519
- Marketing category
- ANDA
- Marketing start
- 2004-11-29
- Substance
- DIMENHYDRINATE
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dimenhydrinate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMENHYDRINATE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JB937PER5C |
| Rxcui | 309914 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-366-00 | Dimenhydrinate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 5 |
| 63323-366-01 | Dimenhydrinate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIMENHYDRINATE | ACTIVE INGREDIENT | JB937PER5C | DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| DIMENHYDRINATE | ACTIVE MOIETY | JB937PER5C | DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-366 | DIMENHYDRINATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250221_bc71539e-1a33-4709-8a24-c2894e8dbc1c.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 |
|---|
| 63323-366-00 | 63323036600 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 63323-366-01 | 63323036601 | 25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00) | 25 vial | 2004-11-29 | 0000-00-00 | No | No | Current |