Ocaliva
- Product NDC
- 69516-005
- 11-digit product format
- 695160005
- Labeler code
- 69516
- Product ID
- 69516-005_1d6c9e9d-e17d-4609-91fa-75e5bdbc5114
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Obeticholic Acid
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Intercept Pharmaceuticals Inc
- Application
- NDA207999
- Marketing category
- NDA
- Marketing start
- 2016-05-27
- Marketing end
- 0000-00-00
- Substance
- OBETICHOLIC ACID
- Active strength
- 5 mg/1
- Pharmacologic classes
- Farnesoid X Receptor Agonist [EPC], Farnesoid X Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69516-005 | OCALIVA (OBETICHOLIC ACID) TABLET, FILM COATED [INTERCEPT PHARMACEUTICALS INC] | 13 | Legacy NDC | 20241109_cdfbe0cd-eb15-45a1-ac17-531bcda21aec.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69516-005-30 | 69516000530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-005-30) | 2016-05-27 | 0000-00-00 | No | No | Current |