Pentasa
- Product NDC
- 69189-0189
- 11-digit product format
- 691890189
- Labeler code
- 69189
- Product ID
- 69189-0189_6618dfe2-5b3c-4357-a0bf-b58901cd367b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Avera McKennan Hospital
- Application
- NDA020049
- Marketing category
- NDA
- Marketing start
- 2015-04-27
- Marketing end
- 0000-00-00
- Substance
- MESALAMINE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC],Aminosalicylic Acids [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 69189-0189-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-260a-f424-e053-dadaa90a57ce | PENTASA ® (mesalamine) Controlled-Release Capsules 250 mg Prescribing Information as of 10/2015 Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69189-0189-1 | Pentasa | 1 in 1 DOSE PACK | CAPSULE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69189-0189 | PENTASA (MESALAMINE) CAPSULE [AVERA MCKENNAN HOSPITAL] | 1 | Legacy NDC, 1 package rows | 20160302_3a4dbb01-3c0f-4217-8e33-e37263878828.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314092 | mesalamine 250 MG Extended Release Oral Capsule | PSN | 3a4dbb01-3c0f-4217-8e33-e37263878828 | 1 |
| 206791 | Pentasa 250 MG Extended Release Oral Capsule | PSN | 3a4dbb01-3c0f-4217-8e33-e37263878828 | 1 |
| 206791 | mesalamine 250 MG Extended Release Oral Capsule [Pentasa] | SBD | 3a4dbb01-3c0f-4217-8e33-e37263878828 | 1 |
| 314092 | mesalamine 250 MG Extended Release Oral Capsule | SCD | 3a4dbb01-3c0f-4217-8e33-e37263878828 | 1 |
| 314092 | mesalazine 250 MG Extended Release Oral Capsule | SY | 3a4dbb01-3c0f-4217-8e33-e37263878828 | 1 |
| 206791 | Pentasa 250 MG Extended Release Oral Capsule | SY | 3a4dbb01-3c0f-4217-8e33-e37263878828 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69189-0189-1 | 69189018901 | 1 in 1 DOSE PACK | Historical |