ASACOL
- Product NDC
- 53808-0823
- 11-digit product format
- 538080823
- Labeler code
- 53808
- Product ID
- 53808-0823_51806be1-d5f5-4a7c-afba-12ebd6234980
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- NDA019651
- Marketing category
- NDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- MESALAMINE
- Active strength
- 400 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0823-1 | ASACOL | 30 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MESALAMINE | ACTIVE INGREDIENT | 4Q81I59GXC | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MESALAMINE | ACTIVE MOIETY | 4Q81I59GXC | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| DIBUTYL PHTHALATE | INACTIVE INGREDIENT | 2286E5R2KE | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0823 | ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20140328_a97c3815-a0d5-4763-8c3f-9caa5dd9b01b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0823-1 | 53808082301 | 30 in 1 BLISTER PACK | Historical |