Cyklokapron
- Product NDC
- 0013-1114
- 11-digit product format
- 000131114
- Labeler code
- 0013
- Product ID
- 0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tranexamic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA019281
- Marketing category
- NDA
- Marketing start
- 1986-12-30
- Substance
- TRANEXAMIC ACID
- Active strength
- 100 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
- Cyklokapron
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRANEXAMIC ACID | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T84R30KC1 |
| Rxcui | 208104, 238720 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0013-1114-01 | Cyklokapron | 10 mL in 1 AMPULE | INJECTION, SOLUTION | 10 | | 34 |
| 0013-1114-10 | Cyklokapron | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 34 |
| 0013-1114-10 | Cyklokapron | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 34 |
| 0013-1114-15 | Cyklokapron | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 34 |
| 0013-1114-20 | Cyklokapron | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 34 |
| 0013-1114-21 | Cyklokapron | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 34 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0013-1114 | CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 33 | Current NDC, Legacy NDC, 6 package rows | 20250216_6e89a7d9-4da4-42aa-b7f8-c602c24eefe5.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 |
|---|
| 0013-1114-01 | 00013111401 | 10 mL in 1 AMPULE | 10 ml | | | | | Historical |
| 0013-1114-10 | 00013111410 | 10 in 1 BOX | | | | | | Historical |
| 0013-1114-15 | 00013111415 | 1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01) | 1 ampule | 2018-11-21 | 0000-00-00 | No | No | Current |
| 0013-1114-20 | 00013111420 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 0013-1114-21 | 00013111421 | 10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20) | 10 vial | 1986-12-30 | 0000-00-00 | No | No | Current |