Amikacin Sulfate
- Product NDC
- 67184-0569
- 11-digit product format
- 671840569
- Labeler code
- 67184
- Product ID
- 67184-0569_0a56f2df-a71f-44a1-b7d0-98ee44e30e80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amikacin Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA218146
- Marketing category
- ANDA
- Marketing start
- 2024-03-19
- Substance
- AMIKACIN SULFATE
- Active strength
- 250 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amikacin Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIKACIN SULFATE | 250 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N6M33094FD |
| Rxcui | 1723156, 1723160 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67184-0569-1 | Amikacin Sulfate | 2 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 2 | | 3 |
| 67184-0569-2 | Amikacin Sulfate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0569 | AMIKACIN SULFATE INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 1 | Current NDC, 2 package rows | 20240326_20fa61ef-11e2-4d01-82ea-b5412cefaead.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67184-0569-1 | 67184056901 | 2 mL in 1 VIAL, GLASS | 2 ml | | | | Historical |
| 67184-0569-2 | 67184056902 | 10 VIAL, GLASS in 1 CARTON (67184-0569-2) / 2 mL in 1 VIAL, GLASS (67184-0569-1) | | 2024-03-19 | No | No | Current |