ephedrine sulfate
- Product NDC
- 65219-548
- 11-digit product format
- 652190548
- Labeler code
- 65219
- Product ID
- 65219-548_de95d79e-ae15-4056-a4e5-ac3380768cdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ephedrine sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA218271
- Marketing category
- ANDA
- Marketing start
- 2025-07-07
- 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
- 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U6X61U5ZEG |
| Rxcui | 2586841, 2631017 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-548-01 | ephedrine sulfate | 10 mL in 1 SYRINGE, PLASTIC | INJECTION | 10 | | 1 |
| 65219-548-10 | ephedrine sulfate | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-548-01 | 65219054801 | 10 mL in 1 SYRINGE, PLASTIC | 10 ml | | | | Historical |
| 65219-548-10 | 65219054810 | 10 SYRINGE, PLASTIC in 1 CARTON (65219-548-10) / 10 mL in 1 SYRINGE, PLASTIC (65219-548-01) | | 2025-07-07 | No | No | Historical |