Tranexamic Acid
- Product NDC
- 63629-8599
- 11-digit product format
- 636298599
- Labeler code
- 63629
- Product ID
- 63629-8599_8d9c163d-5a47-4c45-98bf-b9a59813542a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tranexamic Acid
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202093
- Marketing category
- ANDA
- Marketing start
- 2013-01-03
- Substance
- TRANEXAMIC ACID
- Active strength
- 650 mg/1
- 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
- Tranexamic Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRANEXAMIC ACID | 650 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6T84R30KC1 |
| Rxcui | 883826 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8599-1 | Tranexamic Acid | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8599 | TRANEXAMIC ACID TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 1 package rows | 20231107_4ddba10f-705a-40af-83b8-aa1fd68891f8.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 |
|---|
| 63629-8599-1 | 63629859901 | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-8599-1) | 2021-06-28 | 0000-00-00 | No | No | Current |