Home NDC 0781-8201 Cladribine
Product NDC 0781-8201
11-digit product format 007818201
Labeler code 0781
Product ID 0781-8201_4ff7cb90-f8cc-5804-e063-6394a90ac0a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cladribine
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc.
Application ANDA215547
Marketing category ANDA
Marketing start 2026-04-23
Substance CLADRIBINE
Active strength 10 mg/1
Pharmacologic classes Purine Antimetabolite [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215547-001 CLADRIBINE CLADRIBINE 10MG TABLET / ORAL AB 2026-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215547-001 AB
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215547-001 CLADRIBINE 10MG TABLET / ORAL AB 2026-03-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215547-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Cladribine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLADRIBINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 47M74X9YT5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2122634 Internal RxNorm lookup 2122635 Internal RxNorm lookup 2122647 Internal RxNorm lookup 2122649 Internal RxNorm lookup 2122654 Internal RxNorm lookup 2122656 Internal RxNorm lookup 2122658 Internal RxNorm lookup 2122660 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0781-8201-37 00781820137 9 TABLET in 1 CARTON (0781-8201-37) 9 tablet 2026-04-23 No No Current 0781-8201-51 00781820151 5 TABLET in 1 CARTON (0781-8201-51) 5 tablet 2026-04-23 No No Current 0781-8201-68 00781820168 6 TABLET in 1 CARTON (0781-8201-68) 6 tablet 2026-04-23 No No Current 0781-8201-71 00781820171 7 TABLET in 1 CARTON (0781-8201-71) 7 tablet 2026-04-23 No No Current 0781-8201-80 00781820180 10 TABLET in 1 CARTON (0781-8201-80) 10 tablet 2026-04-23 No No Current 0781-8201-85 00781820185 8 TABLET in 1 CARTON (0781-8201-85) 8 tablet 2026-04-23 No No Current 0781-8201-94 00781820194 4 TABLET in 1 CARTON (0781-8201-94) 4 tablet 2026-04-23 No No Current