NDC 55154-2305
Asacol
Mesalamine
Asacol is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Mesalamine.
| Product ID | 55154-2305_7c7cae76-b83e-44a0-857c-192b28e6f504 |
| NDC | 55154-2305 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Asacol |
| Generic Name | Mesalamine |
| Dosage Form | Tablet, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 1992-04-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019651 |
| Labeler Name | Cardinal Health |
| Substance Name | MESALAMINE |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | Aminosalicylate [EPC],Aminosalicylic Acids [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC SPL Data Element Entries
NDC 55154-2305-0 [55154230500]
Asacol TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA019651 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-01 |
| Marketing End Date | 2012-12-31 |
NDC 55154-2305-2 [55154230502]
Asacol TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA019651 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-01 |
| Marketing End Date | 2012-11-30 |
NDC 55154-2305-6 [55154230506]
Asacol TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA019651 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-01 |
| Marketing End Date | 2012-12-31 |
NDC 55154-2305-4 [55154230504]
Asacol TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA019651 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-01 |
| Marketing End Date | 2012-11-30 |
NDC 55154-2305-8 [55154230508]
Asacol TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA019651 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1992-04-01 |
| Marketing End Date | 2012-11-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MESALAMINE | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | d31a6e7d-31b1-474e-bc7b-821b08115109 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Aminosalicylate [EPC]
- Aminosalicylic Acids [CS]
NDC Crossover Matching brand name "Asacol" or generic name "Mesalamine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 53808-0205 | Asacol | Asacol |
| 53808-0823 | ASACOL | ASACOL |
| 55154-2305 | Asacol | Asacol |
| 0023-5901 | Asacol HD | mesalamine |
| 0430-0783 | ASACOL HD | mesalamine |
| 0023-5853 | Delzicol | mesalamine |
| 0179-0142 | Lialda | mesalamine |
| 0093-5907 | Mesalamine | Mesalamine |
| 0093-9224 | mesalamine | mesalamine |
| 0378-1375 | Mesalamine | mesalamine |
| 0378-9230 | Mesalamine | mesalamine |
| 0472-1915 | Mesalamine | Mesalamine |
| 0037-0066 | Rowasa | mesalamine |
| 0037-0022 | sfRowasa | mesalamine |
Trademark Results [Asacol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASACOL 76560719 3291293 Dead/Cancelled |
MEDEVA PHARMA SUISSE AG 2003-11-17 |
 ASACOL 73465464 1372087 Live/Registered |
J. B. TILLOTT LIMITED 1984-02-13 |
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