Home NDC 79378-002-02 CHOLBAM
Product NDC 79378-002
Requested package NDC 79378-002-02
11-digit product format 793780002
Labeler code 79378
Product ID 79378-002_edddbf7e-e2dd-4ff7-80a0-d73c22fd40ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cholic acid
Dosage form CAPSULE
Route ORAL
Labeler Mirum Pharmaceuticals Inc.
Application NDA205750
Marketing category NDA
Marketing start 2025-05-09
Substance CHOLIC ACID
Active strength 250 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205750-001 CHOLBAM CHOLIC ACID 50MG CAPSULE / ORAL RLD 2015-03-17 N205750-002 CHOLBAM CHOLIC ACID 250MG CAPSULE / ORAL RLD, RS 2015-03-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N205750-001 CHOLBAM 50MG CAPSULE / ORAL RLD 2015-03-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N205750-002 CHOLBAM 250MG CAPSULE / ORAL RLD, RS 2015-03-17 a50c72e98297…
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. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base CHOLBAM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLIC ACID 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G1JO7801AE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1440861 Internal RxNorm lookup 1440868 Internal RxNorm lookup 1608274 Internal RxNorm lookup 1608276 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79378-002-02 CHOLBAM 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79378-002 CHOLBAM (CHOLIC ACID) CAPSULE [MIRUM PHARMACEUTICALS INC.] 1 Current NDC, 1 package rows 20250509_5c6e4c9d-b85e-493f-9420-ab2fd0ff3723.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79378-002-02 79378000202 90 CAPSULE in 1 BOTTLE (79378-002-02) 90 capsule 2025-05-09 No No Current