Application 211358

Type
NDA
Sponsor
VERTEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORKAMBIIVACAFTOR; LUMACAFTORGRANULE;ORAL125MG/PACKET;100MG/PACKETYesNo
002ORKAMBIIVACAFTOR; LUMACAFTORGRANULE;ORAL188MG/PACKET;150MG/PACKETYesYes
003ORKAMBIIVACAFTOR; LUMACAFTORGRANULE;ORAL94MG/PACKET;75MG/PACKETYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211358-001ORKAMBIIVACAFTOR; LUMACAFTOR125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07
N211358-002ORKAMBIIVACAFTOR; LUMACAFTOR188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07
N211358-003ORKAMBIIVACAFTOR; LUMACAFTOR94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02

Orange Book patents#

Current patent rows page 1 of 2 · 126 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211358-00179730382026-11-08U-23742018-09-06
N211358-00187419332026-11-08U-23742018-09-06
N211358-00192169692026-11-08Drug product2018-09-06
N211358-00184102742026-12-28Drug product2018-09-06
N211358-00187542242026-12-28Drug substance, Drug product2018-09-06
N211358-00196701632026-12-28U-2376Drug product2018-09-06
N211358-00199313342026-12-28U-2376Drug product2018-09-06
N211358-0017973038*PED2027-05-08Pediatric extension
N211358-0018741933*PED2027-05-08Pediatric extension
N211358-0019216969*PED2027-05-08Pediatric extension
N211358-00174951032027-05-20Drug substance, Drug product2018-09-06
N211358-0018410274*PED2027-06-28Pediatric extension
N211358-0018754224*PED2027-06-28Pediatric extension
N211358-0019670163*PED2027-06-28Pediatric extension
N211358-0019931334*PED2027-06-28Pediatric extension
N211358-00183242422027-08-05U-23742018-09-06
N211358-0017495103*PED2027-11-20Pediatric extension
N211358-0018324242*PED2028-02-05Pediatric extension
N211358-001105973842028-12-04U-2778Drug substance, Drug product2020-04-23
N211358-001120654322028-12-04U-39832024-09-18
N211358-00186531032028-12-04Drug product2018-09-06
N211358-00191505522028-12-04U-23752018-09-06
N211358-00110597384*PED2029-06-04Pediatric extension
N211358-00112065432*PED2029-06-04Pediatric extension
N211358-0018653103*PED2029-06-04Pediatric extension
N211358-0019150552*PED2029-06-04Pediatric extension
N211358-00188467182029-07-02U-23752018-09-06
N211358-001106464812029-08-13Drug product2020-06-11
N211358-001115649162029-08-13U-35262023-02-28
N211358-001124586352029-08-13U-4335Drug product2025-11-26
N211358-00191926062029-09-29U-2397Drug product2018-09-06
N211358-0018846718*PED2030-01-02Pediatric extension
N211358-00110646481*PED2030-02-13Pediatric extension
N211358-00111564916*PED2030-02-13Pediatric extension
N211358-00112458635*PED2030-02-13Pediatric extension
N211358-0019192606*PED2030-03-29Pediatric extension
N211358-00185075342030-09-20Drug substance, Drug product2018-09-06
N211358-00187163382030-09-20U-2396Drug product2018-09-06
N211358-00189936002030-12-11Drug product2018-09-06
N211358-0018507534*PED2031-03-20Pediatric extension
N211358-0018716338*PED2031-03-20Pediatric extension
N211358-0018993600*PED2031-06-11Pediatric extension
N211358-00279730382026-11-08U-23742018-09-06
N211358-00287419332026-11-08U-23742018-09-06
N211358-00292169692026-11-08Drug product2018-09-06
N211358-00284102742026-12-28Drug product2018-09-06
N211358-00287542242026-12-28Drug substance, Drug product2018-09-06
N211358-00296701632026-12-28U-2376Drug product2018-09-06
N211358-00299313342026-12-28U-2376Drug product2018-09-06
N211358-0027973038*PED2027-05-08Pediatric extension
N211358-0028741933*PED2027-05-08Pediatric extension
N211358-0029216969*PED2027-05-08Pediatric extension
N211358-00274951032027-05-20Drug substance, Drug product2018-09-06
N211358-0028410274*PED2027-06-28Pediatric extension
N211358-0028754224*PED2027-06-28Pediatric extension
N211358-0029670163*PED2027-06-28Pediatric extension
N211358-0029931334*PED2027-06-28Pediatric extension
N211358-00283242422027-08-05U-23742018-09-06
N211358-0027495103*PED2027-11-20Pediatric extension
N211358-0028324242*PED2028-02-05Pediatric extension
N211358-002105973842028-12-04U-2778Drug substance, Drug product2020-04-23
N211358-002120654322028-12-04U-39832024-09-18
N211358-00286531032028-12-04Drug product2018-09-06
N211358-00291505522028-12-04U-23752018-09-06
N211358-00210597384*PED2029-06-04Pediatric extension
N211358-00212065432*PED2029-06-04Pediatric extension
N211358-0028653103*PED2029-06-04Pediatric extension
N211358-0029150552*PED2029-06-04Pediatric extension
N211358-00288467182029-07-02U-23752018-09-06
N211358-002106464812029-08-13Drug product2020-06-11
N211358-002115649162029-08-13U-35262023-02-28
N211358-002124586352029-08-13U-4335Drug product2025-11-26
N211358-00291926062029-09-29U-2397Drug product2018-09-06
N211358-0028846718*PED2030-01-02Pediatric extension
N211358-00210646481*PED2030-02-13Pediatric extension
N211358-00211564916*PED2030-02-13Pediatric extension
N211358-00212458635*PED2030-02-13Pediatric extension
N211358-0029192606*PED2030-03-29Pediatric extension
N211358-00285075342030-09-20Drug substance, Drug product2018-09-06
N211358-00287163382030-09-20U-2396Drug product2018-09-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N211358-001M-142027-12-13
N211358-001PED2028-06-13
N211358-001ODE-4082029-09-02
N211358-001PED2030-03-02
N211358-002M-142027-12-13
N211358-002PED2028-06-13
N211358-002ODE-4082029-09-02
N211358-002PED2030-03-02
N211358-003M-142027-12-13
N211358-003PED2028-06-13
N211358-003ODE-4082029-09-02
N211358-003PED2030-03-02

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 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211358-002ORKAMBI188MG/PACKET;150MG/PACKETGRANULE / ORALRLD, RS2018-08-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211358-003ORKAMBI94MG/PACKET;75MG/PACKETGRANULE / ORALRLD2022-09-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211358-001ORKAMBI125MG/PACKET;100MG/PACKETGRANULE / ORALRLD2018-08-071e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 62 · 2,471 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N211358-00179730382026-11-08U-23742018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00187419332026-11-08U-23742018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00192169692026-11-08Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00184102742026-12-28Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00187542242026-12-28Drug substance, Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00196701632026-12-28U-2376Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00199313342026-12-28U-2376Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0017973038*PED2027-05-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018741933*PED2027-05-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0019216969*PED2027-05-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00174951032027-05-20Drug substance, Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018410274*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018754224*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0019670163*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0019931334*PED2027-06-28Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00183242422027-08-05U-23742018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0017495103*PED2027-11-20Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018324242*PED2028-02-05Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001105973842028-12-04U-2778Drug substance, Drug product2020-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001120654322028-12-04U-39832024-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00186531032028-12-04Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00191505522028-12-04U-23752018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00110597384*PED2029-06-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00112065432*PED2029-06-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018653103*PED2029-06-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0019150552*PED2029-06-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00188467182029-07-02U-23752018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001106464812029-08-13Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001115649162029-08-13U-35262023-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001124586352029-08-13U-4335Drug product2025-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00191926062029-09-29U-2397Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018846718*PED2030-01-02Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00110646481*PED2030-02-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00111564916*PED2030-02-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00112458635*PED2030-02-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0019192606*PED2030-03-29Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00185075342030-09-20Drug substance, Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00187163382030-09-20U-2396Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-00189936002030-12-11Drug product2018-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-0018507534*PED2031-03-20Pediatric extensioncaaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 309 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N211358-001M-142027-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001PED2028-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001ODE-4082029-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-001PED2030-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-002M-142027-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-002PED2028-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-002ODE-4082029-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-002PED2030-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-003M-142027-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-003PED2028-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-003ODE-4082029-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07N211358-003PED2030-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211358-001M-142027-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-001PED2028-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-001ODE-4082029-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-001PED2030-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-002M-142027-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-002PED2028-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-002ODE-4082029-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-002PED2030-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-003M-142027-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-003PED2028-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-003ODE-4082029-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211358-003PED2030-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001ODE-1952025-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001NPP2025-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001M-142027-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001PED2028-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001ODE-4082029-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-001PED2030-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002ODE-1952025-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002NPP2025-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002M-142027-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002PED2028-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002ODE-4082029-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-002PED2030-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-003NS2025-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-003M-142027-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-003PED2028-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211358-003ODE-4082029-09-0231067a03dcf5…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORKAMBILUMACAFTOR AND IVACAFTORVertex Pharmaceuticals Incorporated3fc1c40e-cfac-47a1-9e1a-61ead35706002026-03-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 211358
application number: NDA211358
ndc (product): 51167-122
ndc (product): 51167-900
ndc (product): 51167-500

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51167-122ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-122ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-500ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-500ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-500ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-500ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-500ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-500ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-900ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-900ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-900ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-900ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-900ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent
51167-900ORKAMBIlumacaftor and ivacaftorVertex Pharmaceuticals IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85476SUPPL 2026-03-24
85412SUPPL 2026-03-19
83565SUPPL 2025-09-26
83553SUPPL 2025-09-26
80596SUPPL 2024-12-16
80595SUPPL 2024-12-16
80581SUPPL 2024-12-16
74995SUPPL 2023-08-04
74988SUPPL 2023-08-04
72035SUPPL2022-09-07
72018SUPPL2022-09-06
55155ORIG2018-08-10
55142ORIG2018-08-09
58157ORIG2018-08-07