Prevalite
- Product NDC
- 0245-0036
- 11-digit product format
- 002450036
- Labeler code
- 0245
- Product ID
- 0245-0036_44feb603-0970-9b63-e063-6294a90a7ce5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cholestyramine
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA073263
- Marketing category
- ANDA
- Marketing start
- 1996-02-01
- Marketing end
- 2027-10-31
- Substance
- CHOLESTYRAMINE
- Active strength
- 4 g/5.5g
- Pharmacologic classes
- Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prevalite
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHOLESTYRAMINE | 4 g/5.5g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B33BGI082 |
| Rxcui | 848951, 1801279 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0245-0036-23 | Prevalite | 231 g in 1 CAN | POWDER, FOR SUSPENSION | 231 | | 9 |
| 0245-0036-42 | Prevalite | 42 in 1 CARTON | POWDER, FOR SUSPENSION | 42 | | 9 |
| 0245-0036-60 | Prevalite | 60 in 1 CARTON | POWDER, FOR SUSPENSION | 60 | | 9 |
| 0245-0036-89 | Prevalite | 5.5 g in 1 PACKET | POWDER, FOR SUSPENSION | 5.5 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| cholestyramine | ACTIVE INGREDIENT | 4B33BGI082 | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| cholestyramine | ACTIVE MOIETY | 4B33BGI082 | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| malic acid | INACTIVE INGREDIENT | 817L1N4CKP | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| propylene glycol alginate | INACTIVE INGREDIENT | 26CD3J2R0C | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0245-0036 | PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20200715_dd434ef8-8af3-434c-a0a0-9a0b18459ba0.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 |
|---|
| 0245-0036-23 | 00245003623 | 231 g in 1 CAN (0245-0036-23) | 231 g | 1996-02-01 | 2027-10-31 | No | No | Current |
| 0245-0036-42 | 00245003642 | 42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) | 42 packet | 1996-02-01 | 2027-10-31 | No | No | Current |
| 0245-0036-60 | 00245003660 | 60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89) | 60 packet | 1996-02-01 | 2027-09-30 | No | No | Current |
| 0245-0036-89 | 00245003689 | 5.5 g in 1 PACKET | 5.5 g | | | | | Historical |