Home NDC 51167-809-01 ORKAMBI
Product NDC 51167-809
Requested package NDC 51167-809-01
11-digit product format 511670809
Labeler code 51167
Product ID 51167-809_e746b83a-cec1-40ab-8dba-7d8c1781e8b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lumacaftor and ivacaftor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Vertex Pharmaceuticals Incorporated
Application NDA206038
Marketing category NDA
Marketing start 2015-07-02
Substance IVACAFTOR; LUMACAFTOR
Active strength 125; 200 mg/1; mg/1
Pharmacologic classes Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inducers [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 N206038-001 ORKAMBI IVACAFTOR; LUMACAFTOR 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 N206038-002 ORKAMBI IVACAFTOR; LUMACAFTOR 125MG;100MG TABLET / ORAL RLD 2016-09-28
Orange Book patents# Current patent rows page 1 of 2 · 94 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206038-001 7973038 2026-11-08 U-1973 2016-10-21 N206038-001 8741933 2026-11-08 U-1717 2015-07-22 N206038-001 8741933 2026-11-08 U-1909 2015-07-22 N206038-001 9216969 2026-11-08 Drug substance, Drug product 2016-03-15 N206038-001 8410274 2026-12-28 Drug product 2015-07-22 N206038-001 8754224 2026-12-28 Drug substance, Drug product 2015-07-22 N206038-001 9670163 2026-12-28 U-1911 Drug product 2017-07-05 N206038-001 9931334 2026-12-28 U-2276 Drug product 2018-05-02 N206038-001 7973038*PED 2027-05-08 Pediatric extension N206038-001 8741933*PED 2027-05-08 Pediatric extension N206038-001 9216969*PED 2027-05-08 Pediatric extension N206038-001 7495103 2027-05-20 Drug substance, Drug product 2015-07-22 N206038-001 8410274*PED 2027-06-28 Pediatric extension N206038-001 8754224*PED 2027-06-28 Pediatric extension N206038-001 9670163*PED 2027-06-28 Pediatric extension N206038-001 9931334*PED 2027-06-28 Pediatric extension N206038-001 8324242 2027-08-05 U-1311 2015-07-22 N206038-001 8324242 2027-08-05 U-1911 2015-07-22 N206038-001 7495103*PED 2027-11-20 Pediatric extension N206038-001 8324242*PED 2028-02-05 Pediatric extension N206038-001 10076513 2028-12-04 U-2411 Drug product 2018-10-18 N206038-001 10597384 2028-12-04 U-2777 Drug substance, Drug product 2020-04-23 N206038-001 11052075 2028-12-04 U-3181 Drug product 2021-08-04 N206038-001 12065432 2028-12-04 U-3984 2024-09-18 N206038-001 8653103 2028-12-04 Drug product 2015-07-22 N206038-001 9150552 2028-12-04 U-1908 2016-10-21 N206038-001 10076513*PED 2029-06-04 Pediatric extension N206038-001 10597384*PED 2029-06-04 Pediatric extension N206038-001 11052075*PED 2029-06-04 Pediatric extension N206038-001 12065432*PED 2029-06-04 Pediatric extension N206038-001 8653103*PED 2029-06-04 Pediatric extension N206038-001 9150552*PED 2029-06-04 Pediatric extension N206038-001 8846718 2029-07-02 U-1717 2015-07-22 N206038-001 8846718 2029-07-02 U-1908 2015-07-22 N206038-001 10646481 2029-08-13 Drug product 2020-06-11 N206038-001 11564916 2029-08-13 U-3529 2023-02-28 N206038-001 12458635 2029-08-13 U-4338 Drug product 2025-11-26 N206038-001 9192606 2029-09-29 U-1912 Drug product 2016-10-21 N206038-001 8846718*PED 2030-01-02 Pediatric extension N206038-001 10646481*PED 2030-02-13 Pediatric extension N206038-001 11564916*PED 2030-02-13 Pediatric extension N206038-001 12458635*PED 2030-02-13 Pediatric extension N206038-001 9192606*PED 2030-03-29 Pediatric extension N206038-001 8507534 2030-09-20 Drug substance, Drug product 2015-07-22 N206038-001 8716338 2030-09-20 U-1718 Drug product 2015-07-22 N206038-001 8716338 2030-09-20 U-1910 Drug product 2015-07-22 N206038-001 8993600 2030-12-11 Drug product 2015-07-22 N206038-001 8507534*PED 2031-03-20 Pediatric extension N206038-001 8716338*PED 2031-03-20 Pediatric extension N206038-001 8993600*PED 2031-06-11 Pediatric extension N206038-002 7973038 2026-11-08 U-1973 2016-10-21 N206038-002 8741933 2026-11-08 U-1909 2016-10-21 N206038-002 9216969 2026-11-08 Drug product 2016-10-21 N206038-002 8410274 2026-12-28 Drug product 2016-10-21 N206038-002 8754224 2026-12-28 Drug substance, Drug product 2016-10-21 N206038-002 9670163 2026-12-28 U-1911 Drug product 2017-07-05 N206038-002 9931334 2026-12-28 U-2276 Drug product 2018-05-02 N206038-002 7973038*PED 2027-05-08 Pediatric extension N206038-002 8741933*PED 2027-05-08 Pediatric extension N206038-002 9216969*PED 2027-05-08 Pediatric extension N206038-002 7495103 2027-05-20 Drug substance, Drug product 2016-10-21 N206038-002 8410274*PED 2027-06-28 Pediatric extension N206038-002 8754224*PED 2027-06-28 Pediatric extension N206038-002 9670163*PED 2027-06-28 Pediatric extension N206038-002 9931334*PED 2027-06-28 Pediatric extension N206038-002 8324242 2027-08-05 U-1911 2016-10-21 N206038-002 7495103*PED 2027-11-20 Pediatric extension N206038-002 8324242*PED 2028-02-05 Pediatric extension N206038-002 10597384 2028-12-04 U-2777 Drug substance, Drug product 2020-04-23 N206038-002 11052075 2028-12-04 U-3181 Drug product 2021-08-04 N206038-002 12065432 2028-12-04 U-3984 2024-09-18 N206038-002 8653103 2028-12-04 Drug product 2016-10-21 N206038-002 9150552 2028-12-04 U-1908 2016-10-21 N206038-002 10597384*PED 2029-06-04 Pediatric extension N206038-002 11052075*PED 2029-06-04 Pediatric extension N206038-002 12065432*PED 2029-06-04 Pediatric extension N206038-002 8653103*PED 2029-06-04 Pediatric extension N206038-002 9150552*PED 2029-06-04 Pediatric extension N206038-002 8846718 2029-07-02 U-1908 2016-10-21 N206038-002 10646481 2029-08-13 Drug product 2020-06-11
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 51 · 2,024 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206038-001 7973038 2026-11-08 U-1973 2016-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8741933 2026-11-08 U-1909 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8741933 2026-11-08 U-1717 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9216969 2026-11-08 Drug substance, Drug product 2016-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8410274 2026-12-28 Drug product 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8754224 2026-12-28 Drug substance, Drug product 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9670163 2026-12-28 U-1911 Drug product 2017-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9931334 2026-12-28 U-2276 Drug product 2018-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 7973038*PED 2027-05-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8741933*PED 2027-05-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9216969*PED 2027-05-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 7495103 2027-05-20 Drug substance, Drug product 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8410274*PED 2027-06-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8754224*PED 2027-06-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9670163*PED 2027-06-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9931334*PED 2027-06-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8324242 2027-08-05 U-1311 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8324242 2027-08-05 U-1911 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 7495103*PED 2027-11-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8324242*PED 2028-02-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 10076513 2028-12-04 U-2411 Drug product 2018-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 10597384 2028-12-04 U-2777 Drug substance, Drug product 2020-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 11052075 2028-12-04 U-3181 Drug product 2021-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 12065432 2028-12-04 U-3984 2024-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8653103 2028-12-04 Drug product 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9150552 2028-12-04 U-1908 2016-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 10076513*PED 2029-06-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 10597384*PED 2029-06-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 11052075*PED 2029-06-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 12065432*PED 2029-06-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8653103*PED 2029-06-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9150552*PED 2029-06-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8846718 2029-07-02 U-1717 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8846718 2029-07-02 U-1908 2015-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 10646481 2029-08-13 Drug product 2020-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 11564916 2029-08-13 U-3529 2023-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 12458635 2029-08-13 U-4338 Drug product 2025-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 9192606 2029-09-29 U-1912 Drug product 2016-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 8846718*PED 2030-01-02 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-001 10646481*PED 2030-02-13 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 118 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ORKAMBI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUMACAFTOR 125 mg/1 IVACAFTOR 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Y740ILL1Z Internal UNII lookup EGP8L81APK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1655928 Internal RxNorm lookup 1655934 Internal RxNorm lookup 1812468 Internal RxNorm lookup 1812470 Internal RxNorm lookup 2053509 Internal RxNorm lookup 2053512 Internal RxNorm lookup 2053517 Internal RxNorm lookup 2053519 Internal RxNorm lookup 2611458 Internal RxNorm lookup 2611460 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-01-30 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2024-01-30 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2024-01-30 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2022-08-04 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2022-08-04 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2022-08-04 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2022-07-29 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2022-07-29 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015 2022-07-29 These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 2015
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51167-809-01 ORKAMBI 4 in 1 BOX TABLET, FILM COATED 4 24 51167-809-01 ORKAMBI 7 in 1 CARTON TABLET, FILM COATED 7 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ivacaftor ACTIVE INGREDIENT 1Y740ILL1Z ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 lumacaftor ACTIVE INGREDIENT EGP8L81APK ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 ivacaftor ACTIVE MOIETY 1Y740ILL1Z ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 lumacaftor ACTIVE MOIETY EGP8L81APK ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 CARMINIC ACID INACTIVE INGREDIENT CID8Z8N95N ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) INACTIVE INGREDIENT 6N003M473W ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51167-809 ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLET, FILM COATED ORKAMBI (LUMACAFTOR AND IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] 21 Current NDC, Legacy NDC, 2 package rows 20241222_3fc1c40e-cfac-47a1-9e1a-61ead3570600.zip
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 Marketing end Sample Exclude flag Status 51167-809-01 51167080901 4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK 4 carton 2015-07-02 0000-00-00 No No Current