mesalamine
- Product NDC
- 68382-649
- 11-digit product format
- 683820649
- Labeler code
- 68382
- Product ID
- 68382-649_8a3f36df-81c9-4273-9926-9de80237396d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- NDA021830
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-08-01
- Marketing end
- 0000-00-00
- Substance
- MESALAMINE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC],Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c403bb07-2e2f-647c-b633-3f06ae7ddbe3 | Product name | 3 | 20260128 |
| 37997c2c-8686-b078-51f1-fb15da0c0a1c | Product name | 6 | 20260127 |
| 97851e97-0a12-4d74-aaa4-9583fe070304 | Product name | 2 | 20250318 |
| 194d5e54-52c4-1a5e-51c5-1224f8e44e49 | Product name | 5 | 20250317 |
| 4b8d62b1-86bf-0c4e-9f22-ebffb45e4564 | Product name | 5 | 20240514 |
| f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3 | Product name | 1 | 20230124 |
| a4dbd90c-f616-c999-40d7-60da88952163 | Product name | 2 | 20190802 |
| 77831c26-5062-ed63-fc15-a07600377b5b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68382-649-28 | 2024-08-20 | C162847 | 48780-1 | 9d75b9d0-3691-f424-e053-dadaa90a57ce | 5adf08f2-9779-45b2-9340-81ae4af550ce |
| 68382-649-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3691-f424-e053-dadaa90a57ce | 5adf08f2-9779-45b2-9340-81ae4af550ce |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-649-28 | EA - Each | 68382-649 | 9bc1f065-3e6d-45c5-88f0-c3f2f2f9d971 | 1 | 2017-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 833234 | mesalamine 800 MG Delayed Release Oral Tablet | PSN | 25998d2b-4260-4cf8-8a54-a15ee3292da4 | 7 |
| 833234 | mesalamine 800 MG Delayed Release Oral Tablet | SCD | 25998d2b-4260-4cf8-8a54-a15ee3292da4 | 7 |
| 833234 | mesalazine 800 MG Delayed Release Oral Tablet | SY | 25998d2b-4260-4cf8-8a54-a15ee3292da4 | 7 |