Aminocaproic Acid
- Product NDC
- 0517-9191
- 11-digit product format
- 005179191
- Labeler code
- 0517
- Product ID
- 0517-9191_eea945f2-15ce-4ac9-b786-90f68f6e634c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aminocaproic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA071192
- Marketing category
- ANDA
- Marketing start
- 2019-02-01
- Substance
- AMINOCAPROIC ACID
- Active strength
- 250 mg/mL
- Pharmacologic classes
- Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aminocaproic Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMINOCAPROIC ACID | 250 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U6F3787206 |
| Rxcui | 238719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-9191-01 | Aminocaproic Acid | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 4 |
| 0517-9191-25 | Aminocaproic Acid | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-9191 | AMINOCAPROIC ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220107_08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae.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 |
|---|
| 0517-9191-01 | 00517919101 | 20 mL in 1 VIAL, MULTI-DOSE | 20 ml | | | | | Historical |
| 0517-9191-25 | 00517919125 | 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01) | | 2019-02-01 | 0000-00-00 | No | No | Current |