Mesalamine
- Product NDC
- 45802-929
- 11-digit product format
- 458020929
- Labeler code
- 45802
- Product ID
- 45802-929_5c0cc687-bc62-4ae2-adae-aeb4a5d608bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- KIT
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA076751
- Marketing category
- ANDA
- Marketing start
- 2018-08-02
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-098-46 | Mesalamine | 60 mL in 1 BOTTLE | ENEMA | 420 mL | 4 g in 60mL | 8 |
| 45802-929-49 | Mesalamine | 1 in 1 CARTON | KIT | 1 | | 8 |
| 45802-929-49 | Mesalamine | 4 in 1 KIT | KIT | 4 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-929 | MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241017_b2a5b110-7537-4ffc-bf0a-f0fe13379c9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-098-46 | 45802009846 | 60 mL in 1 BOTTLE | 60 ml | | | | | Historical |
| 45802-929-49 | 45802092949 | 4 CARTON in 1 KIT (45802-929-49) / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET | 4 carton | 2018-08-02 | 0000-00-00 | No | No | Current |