Aminocaproic Acid
- Product NDC
- 0054-1100
- 11-digit product format
- 000541100
- Labeler code
- 0054
- Product ID
- 0054-1100_7b8f0ddb-00fd-4c22-afae-afe636f95f3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aminocaproic Acid
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA015230
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-03-12
- Substance
- AMINOCAPROIC ACID
- Active strength
- .25 g/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 | .25 g/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U6F3787206 |
| Rxcui | 476271, 582299 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-1100-58 | Aminocaproic Acid | 236.5 mL in 1 BOTTLE, PLASTIC | SYRUP | 236.5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-1100 | AMINOCAPROIC ACID TABLET AMINOCAPROIC ACID SYRUP [HIKMA PHARMACEUTICALS USA INC.] | 1 | Current NDC, 1 package rows | 20241114_7b8f0ddb-00fd-4c22-afae-afe636f95f3a.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 |
|---|
| 0054-1100-58 | 00054110058 | 236.5 mL in 1 BOTTLE, PLASTIC (0054-1100-58) | 236.5 ml | 2024-11-12 | No | No | Current |