Home NDC 45043-001 Cholbam
Product NDC 45043-001
11-digit product format 450430001
Labeler code 45043
Product ID 45043-001_83e385b7-54bc-4ee2-b477-4e7524508ee3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cholic Acid
Dosage form CAPSULE
Route ORAL
Labeler Manchester Pharmaceuticals, LLC
Application NDA205750
Marketing category NDA
Marketing start 2015-03-31
Marketing end 0000-00-00
Substance CHOLIC ACID
Active strength 50 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHOLBAM CHOLIC ACID Mirum Pharmaceuticals Inc. 5c6e4c9d-b85e-493f-9420-ab2fd0ff3723 2026-01-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 205750 application number: NDA205750
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45043-001 CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS, LLC] 9 Legacy NDC 20230404_e5b67402-8550-4604-97a0-c7b149fbf753.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45043-001-02 45043000102 90 CAPSULE in 1 BOTTLE (45043-001-02) 90 capsule 2015-03-31 0000-00-00 No No Current