Leader Fiber
- Product NDC
- 53808-0963
- 11-digit product format
- 538080963
- Labeler code
- 53808
- Product ID
- 53808-0963_ce8f069a-db9a-4f98-856f-cccc4fb48d45
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calcium polycarbophil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- part334
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- CALCIUM POLYCARBOPHIL
- Active strength
- 625 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0963-1 | Leader Fiber | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CALCIUM POLYCARBOPHIL | ACTIVE INGREDIENT | 8F049NKY49 | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYCARBOPHIL | ACTIVE MOIETY | W25LM17A4W | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 200 | INACTIVE INGREDIENT | R95B8J264J | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0963 | LEADER FIBER (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20141007_e7d790fb-5dfc-4628-a70b-f617581e1ee6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0963-1 | 53808096301 | 30 in 1 BLISTER PACK | Historical |