Niacin
- Product NDC
- 68151-6840
- 11-digit product format
- 681516840
- Labeler code
- 68151
- Product ID
- 68151-6840_a1622254-ca4b-40ff-909f-5b68aa144fa5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Niacin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA076378
- Marketing category
- ANDA
- Marketing start
- 2013-09-20
- Marketing end
- 0000-00-00
- Substance
- NIACIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nicotinic Acid [EPC],Nicotinic Acids [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-6840-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1786-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Niacin Extended-Release Tablets, USP safely and effectively. See full prescribing information for Niacin Extended-Release Tablets, USP. NIACIN extended-release tablets, for oral use. Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-6840-1 | Niacin | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-6840 | NIACIN TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20171227_44335547-b1a5-424a-b8a9-692aa26f02be.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1098141 | niacin 500 MG 24HR Extended Release Oral Tablet | PSN | 44335547-b1a5-424a-b8a9-692aa26f02be | 2 |
| 1098141 | 24 HR niacin 500 MG Extended Release Oral Tablet | SCD | 44335547-b1a5-424a-b8a9-692aa26f02be | 2 |
| 1098141 | 24 HR nicotinic acid 500 MG Extended Release Oral Tablet | SY | 44335547-b1a5-424a-b8a9-692aa26f02be | 2 |
| 1098141 | 24 HR vit-B3 500 MG Extended Release Oral Tablet | SY | 44335547-b1a5-424a-b8a9-692aa26f02be | 2 |
| 1098141 | 24 HR vitamin B3 500 MG Extended Release Oral Tablet | SY | 44335547-b1a5-424a-b8a9-692aa26f02be | 2 |
| 1098141 | niacin 500 MG 24 HR Extended Release Oral Tablet | SY | 44335547-b1a5-424a-b8a9-692aa26f02be | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-6840-1 | 68151684001 | 1 in 1 BLISTER PACK | Historical |