Ephedrine Sulfate
- Product NDC
- 65219-257
- 11-digit product format
- 652190257
- Labeler code
- 65219
- Product ID
- 65219-257_453036d8-bcc1-45a2-a905-edb03a8b743a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ephedrine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA209646
- Marketing category
- ANDA
- Marketing start
- 2020-10-31
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ephedrine Sulfate
- Listing expiration
- 2026-12-31
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 |
|---|
| 65219-257-00 | Ephedrine Sulfate | 1 mL in 1 VIAL, GLASS | INJECTION | 1 | | 2 |
| 65219-257-01 | Ephedrine Sulfate | 25 in 1 CARTON | INJECTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-257 | EPHEDRINE SULFATE INJECTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220827_5ecd9746-25c7-4bd4-9503-eb97e7db5aa5.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 |
|---|
| 65219-257-00 | 65219025700 | 1 mL in 1 VIAL, GLASS | 1 ml | | | | | Historical |
| 65219-257-01 | 65219025701 | 25 VIAL, GLASS in 1 CARTON (65219-257-01) / 1 mL in 1 VIAL, GLASS (65219-257-00) | | 2020-10-31 | 0000-00-00 | No | No | Current |