NDC 50090-3002
Delzicol
Mesalamine
Delzicol is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Mesalamine.
| Product ID | 50090-3002_579f38cd-bef1-4467-88ec-e1cb8e06d453 |
| NDC | 50090-3002 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Delzicol |
| Generic Name | Mesalamine |
| Dosage Form | Capsule, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-05-16 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204412 |
| Labeler Name | A-S Medication Solutions |
| Substance Name | MESALAMINE |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | Aminosalicylate [EPC],Aminosalicylic Acids [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 50090-3002-0
180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3002-0)
| Marketing Start Date | 2017-05-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50090-3002-0 [50090300200]
Delzicol CAPSULE, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA204412 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-05-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MESALAMINE | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | 9d047e43-60c5-4d32-bd5e-204dee863afd |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Aminosalicylate [EPC]
- Aminosalicylic Acids [CS]
NDC Crossover Matching brand name "Delzicol" or generic name "Mesalamine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0023-5853 | Delzicol | mesalamine |
| 68151-5652 | Delzicol | Delzicol |
| 50090-3002 | Delzicol | Delzicol |
| 0023-5901 | Asacol HD | mesalamine |
| 0430-0783 | ASACOL HD | 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 [Delzicol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELZICOL 85808925 4372504 Live/Registered |
ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED 2012-12-21 |
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