EPHEDRINE SULFATE
- Product NDC
- 42023-243
- 11-digit product format
- 420230243
- Labeler code
- 42023
- Product ID
- 42023-243_9e5e9ba2-7ff5-4462-963c-dd92114792e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ephedrine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Par Health USA, LLC
- Application
- NDA213994
- Marketing category
- NDA
- Marketing start
- 2021-01-31
- Substance
- EPHEDRINE SULFATE
- Active strength
- 5 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U6X61U5ZEG |
| Rxcui | 2368456, 2586841 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42023-243-99 | EPHEDRINE SULFATE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 14 |
| 42023-243-01 | EPHEDRINE SULFATE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-243 | EPHEDRINE SULFATE INJECTION [ENDO USA, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20241122_a247857e-ba7b-4a37-b132-4ba9b0d1c4d1.zip |
| 42023-243 | EPHEDRINE SULFATE INJECTION [ENDO USA, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240425_2c203482-8a04-40fc-93d2-74b30dec7742.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 |
|---|
| 42023-243-01 | 42023024301 | 10 mL in 1 VIAL, SINGLE-DOSE (42023-243-01) | 10 ml | 2021-01-31 | 0000-00-00 | No | No | Current |
| 42023-243-99 | 42023024399 | 10 mL in 1 VIAL, SINGLE-DOSE (42023-243-99) | 10 ml | 2024-01-31 | | No | No | Current |