Ephedrine Sulfate
- Product NDC
- 68083-495
- 11-digit product format
- 680830495
- Labeler code
- 68083
- Product ID
- 68083-495_0b79ab41-7c76-4459-8021-57b4364d7dcd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ephedrine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216146
- Marketing category
- ANDA
- Marketing start
- 2022-02-25
- 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 |
|---|
| 68083-495-25 | Ephedrine Sulfate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 4 |
| 68083-495-25 | Ephedrine Sulfate | 25 in 1 CARTON | INJECTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-495 | EPHEDRINE SULFATE INJECTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220304_4a66e6c1-6d01-46fa-a2da-566fbf6e11a4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-495-25 | 68083049525 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-495-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-02-25 | 0000-00-00 | No | No | Current |