ZALDYON
- Product NDC
- 70771-1353
- 11-digit product format
- 707711353
- Labeler code
- 70771
- Product ID
- 70771-1353_a82b38a9-8d59-4a84-a25a-4bf479c4843d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA203286
- Marketing category
- ANDA
- Marketing start
- 2019-01-17
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1353 | ZALDYON (MESALAMINE) TABLET, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 4 | Legacy NDC | 20221019_3256744b-e6fe-41d6-85b9-a705b7c7ce86.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1353-4 | 70771135304 | 10 BLISTER PACK in 1 CARTON (70771-1353-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1353-2) | 10 blister pack | 2019-01-17 | 0000-00-00 | No | No | Current |
| 70771-1353-8 | 70771135308 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1353-8) | | 2019-01-17 | 0000-00-00 | No | No | Current |