Ephedrine Sulfate
- Product NDC
- 42023-216
- 11-digit product format
- 420230216
- Labeler code
- 42023
- Product ID
- 42023-216_3aaa566f-1bff-4084-8578-60e1b66013e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ephedrine Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Par Health USA, LLC
- Application
- NDA208943
- Marketing category
- NDA
- Marketing start
- 2017-02-16
- Substance
- EPHEDRINE SULFATE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ephedrine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPHEDRINE SULFATE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U6X61U5ZEG |
| Rxcui | 1116294 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42023-216-01 | Ephedrine Sulfate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 10 |
| 42023-216-25 | Ephedrine Sulfate | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 10 |
| 42023-216-83 | Ephedrine Sulfate | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 7 |
| 42023-216-83 | Ephedrine Sulfate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-216 | EPHEDRINE SULFATE INJECTION, SOLUTION [ENDO USA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240425_38723cb3-dfca-4c81-8c6f-63dd99929191.zip |
| 42023-216 | EPHEDRINE SULFATE INJECTION, SOLUTION [ENDO USA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241018_3e43cc8e-bf4e-44ef-a07d-4336367b9bdb.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 |
|---|
| 42023-216-01 | 42023021601 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 42023-216-25 | 42023021625 | 25 VIAL in 1 CARTON (42023-216-25) / 1 mL in 1 VIAL (42023-216-01) | 25 vial | 2017-02-16 | 0000-00-00 | No | No | Current |
| 42023-216-83 | 42023021683 | 25 VIAL in 1 CARTON (42023-216-83) / 1 mL in 1 VIAL | 25 vial | 2018-06-26 | 0000-00-00 | No | No | Current |