COLESEVELAM
- Product NDC
- 70771-1368
- 11-digit product format
- 707711368
- Labeler code
- 70771
- Product ID
- 70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COLESEVELAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA207765
- Marketing category
- ANDA
- Marketing start
- 2019-10-11
- Substance
- COLESEVELAM HYDROCHLORIDE
- Active strength
- 625 mg/1
- Pharmacologic classes
- Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A207765-001 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET / ORAL | AB | | 2019-10-07 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A207765-001 | AB |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COLESEVELAM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COLESEVELAM HYDROCHLORIDE | 625 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P4SG24WI5Q |
| Rxcui | 866910 |
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 |
|---|
| 70771-1368-0 | COLESEVELAM | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
| 70771-1368-2 | COLESEVELAM | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 70771-1368-4 | COLESEVELAM | 10 in 1 CARTON | TABLET | 10 | | 5 |
| 70771-1368-8 | COLESEVELAM | 180 in 1 BOTTLE | TABLET | 180 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1368 | COLESEVELAM TABLET [ZYDUS LIFESCIENCES LIMITED] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241130_090eabd5-acd3-43ed-a05b-52f1f3773a93.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 |
|---|
| 70771-1368-0 | 70771136800 | 1000 TABLET in 1 BOTTLE (70771-1368-0) | 1000 tablet | 2019-10-11 | 0000-00-00 | No | No | Current |
| 70771-1368-2 | 70771136802 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70771-1368-4 | 70771136804 | 10 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2) | 10 blister pack | 2019-10-11 | 0000-00-00 | No | No | Current |
| 70771-1368-8 | 70771136808 | 180 TABLET in 1 BOTTLE (70771-1368-8) | 180 tablet | 2019-10-11 | 0000-00-00 | No | No | Current |