Home NDC 51167-135 ALYFTREK
Product NDC 51167-135
11-digit product format 511670135
Labeler code 51167
Product ID 51167-135_9b4cc7f5-485c-42a5-ab1c-748b441cc9e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vanzacaftor, tezacaftor, and deutivacaftor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Vertex Pharmaceuticals Incorporated
Application NDA218730
Marketing category NDA
Marketing start 2024-12-20
Substance DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR
Active strength 50; 20; 4 mg/1; mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2C9 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 43 .
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 N218730-001 ALYFTREK DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 N218730-002 ALYFTREK DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20
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 N218730-001 8354427 2026-07-06 U-4091 2025-01-17 N218730-001 8410274 2026-12-28 Drug product 2025-01-17 N218730-001 8754224 2026-12-28 Drug substance, Drug product 2025-01-17 N218730-001 9670163 2026-12-28 U-4080 Drug product 2025-01-17 N218730-001 9670163 2026-12-28 U-4470 Drug product 2025-01-17 N218730-001 9931334 2026-12-28 U-4080 Drug product 2025-01-17 N218730-001 9931334 2026-12-28 U-4469 Drug product 2025-01-17 N218730-001 10022352 2027-04-09 U-4081 Drug product 2025-01-17 N218730-001 10239867 2027-04-09 U-4090 Drug substance, Drug product 2025-01-17 N218730-001 10239867 2027-04-09 U-4464 Drug substance, Drug product 2025-01-17 N218730-001 11639347 2027-04-09 U-4090 Drug substance, Drug product 2025-01-17 N218730-001 11639347 2027-04-09 U-4464 Drug substance, Drug product 2025-01-17 N218730-001 9974781 2027-04-09 U-4082 Drug product 2025-01-17 N218730-001 9974781 2027-04-09 U-4463 Drug product 2025-01-17 N218730-001 7645789 2027-05-01 Drug substance, Drug product 2025-01-17 N218730-001 8598181 2027-05-01 U-4090 2025-01-17 N218730-001 8598181 2027-05-01 U-4463 2025-01-17 N218730-001 8623905 2027-05-01 Drug substance, Drug product 2025-01-17 N218730-001 7495103 2027-05-20 Drug substance, Drug product 2025-01-17 N218730-001 7776905 2027-06-03 Drug substance, Drug product 2025-01-17 N218730-001 8324242 2027-08-05 U-4090 2025-01-17 N218730-001 8324242 2027-08-05 U-4464 2025-01-17 N218730-001 8415387 2027-11-12 U-4082 2025-01-17 N218730-001 8415387 2027-11-12 U-4463 2025-01-17 N218730-001 10646481 2029-08-13 Drug product 2025-01-17 N218730-001 11564916 2029-08-13 U-4095 2025-01-17 N218730-001 11564916 2029-08-13 U-4466 2025-01-17 N218730-001 10081621 2031-03-25 U-4087 Drug product 2025-01-17 N218730-001 10081621 2031-03-25 U-4468 Drug product 2025-01-17 N218730-001 11578062 2031-03-25 U-4096 Drug product 2025-01-17 N218730-001 11578062 2031-03-25 U-4465 Drug product 2025-01-17 N218730-001 RE50453 2031-07-10 Drug substance, Drug product 2025-07-09 N218730-001 10047053 2032-05-17 Drug substance 2025-01-17 N218730-001 8865902 2032-05-17 Drug substance, Drug product 2025-01-17 N218730-001 9181192 2032-05-17 U-4094 Drug substance, Drug product 2025-01-17 N218730-001 9181192 2032-05-17 U-4472 Drug substance, Drug product 2025-01-17 N218730-001 9512079 2032-05-17 U-4098 Drug substance, Drug product 2025-01-17 N218730-001 9512079 2032-05-17 U-4471 Drug substance, Drug product 2025-01-17 N218730-001 11066417 2039-02-14 Drug substance, Drug product 2025-01-17 N218730-001 11866450 2039-02-14 U-4082 2025-01-17 N218730-001 11866450 2039-02-14 U-4463 2025-01-17 N218730-001 11873300 2040-08-13 U-4083 Drug substance, Drug product 2025-01-17 N218730-001 11873300 2040-08-13 U-4462 Drug substance, Drug product 2025-01-17 N218730-002 8354427 2026-07-06 U-4091 2025-01-17 N218730-002 8410274 2026-12-28 Drug product 2025-01-17 N218730-002 8754224 2026-12-28 Drug substance, Drug product 2025-01-17 N218730-002 9670163 2026-12-28 U-4080 Drug product 2025-01-17 N218730-002 9670163 2026-12-28 U-4470 Drug product 2025-01-17 N218730-002 9931334 2026-12-28 U-4080 Drug product 2025-01-17 N218730-002 9931334 2026-12-28 U-4469 Drug product 2025-01-17 N218730-002 10022352 2027-04-09 U-4081 Drug product 2025-01-17 N218730-002 10239867 2027-04-09 U-4090 Drug substance, Drug product 2025-01-17 N218730-002 10239867 2027-04-09 U-4464 Drug substance, Drug product 2025-01-17 N218730-002 11639347 2027-04-09 U-4090 Drug substance, Drug product 2025-01-17 N218730-002 11639347 2027-04-09 U-4464 Drug substance, Drug product 2025-01-17 N218730-002 9974781 2027-04-09 U-4082 Drug product 2025-01-17 N218730-002 9974781 2027-04-09 U-4463 Drug product 2025-01-17 N218730-002 7645789 2027-05-01 Drug substance, Drug product 2025-01-17 N218730-002 8598181 2027-05-01 U-4090 2025-01-17 N218730-002 8598181 2027-05-01 U-4463 2025-01-17 N218730-002 8623905 2027-05-01 Drug substance, Drug product 2025-01-17 N218730-002 7495103 2027-05-20 Drug substance, Drug product 2025-01-17 N218730-002 7776905 2027-06-03 Drug substance, Drug product 2025-01-17 N218730-002 8324242 2027-08-05 U-4090 2025-01-17 N218730-002 8324242 2027-08-05 U-4464 2025-01-17 N218730-002 8415387 2027-11-12 U-4082 2025-01-17 N218730-002 8415387 2027-11-12 U-4463 2025-01-17 N218730-002 10646481 2029-08-13 Drug product 2025-01-17 N218730-002 11564916 2029-08-13 U-4095 2025-01-17 N218730-002 11564916 2029-08-13 U-4466 2025-01-17 N218730-002 10081621 2031-03-25 U-4087 Drug product 2025-01-17 N218730-002 10081621 2031-03-25 U-4468 Drug product 2025-01-17 N218730-002 11578062 2031-03-25 U-4096 Drug product 2025-01-17 N218730-002 11578062 2031-03-25 U-4465 Drug product 2025-01-17 N218730-002 RE50453 2031-07-10 Drug substance, Drug product 2025-07-09 N218730-002 10047053 2032-05-17 Drug substance 2025-01-17 N218730-002 8865902 2032-05-17 Drug substance, Drug product 2025-01-17 N218730-002 9181192 2032-05-17 U-4094 Drug substance, Drug product 2025-01-17 N218730-002 9181192 2032-05-17 U-4472 Drug substance, Drug product 2025-01-17 N218730-002 9512079 2032-05-17 U-4098 Drug substance, Drug product 2025-01-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 2026-09-14 22:38:34 2026-08 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218730-001 ALYFTREK 50MG;20MG;EQ 4MG BASE TABLET / ORAL RLD 2024-12-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218730-002 ALYFTREK 125MG;50MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2024-12-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 15 · 591 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218730-001 8354427 2026-07-06 U-4091 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8410274 2026-12-28 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8754224 2026-12-28 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9670163 2026-12-28 U-4080 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9670163 2026-12-28 U-4470 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9931334 2026-12-28 U-4080 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9931334 2026-12-28 U-4469 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10022352 2027-04-09 U-4081 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10239867 2027-04-09 U-4090 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10239867 2027-04-09 U-4464 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11639347 2027-04-09 U-4090 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11639347 2027-04-09 U-4464 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9974781 2027-04-09 U-4082 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9974781 2027-04-09 U-4463 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 7645789 2027-05-01 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8598181 2027-05-01 U-4090 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8598181 2027-05-01 U-4463 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8623905 2027-05-01 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 7495103 2027-05-20 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 7776905 2027-06-03 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8324242 2027-08-05 U-4090 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8324242 2027-08-05 U-4464 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8415387 2027-11-12 U-4082 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8415387 2027-11-12 U-4463 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10646481 2029-08-13 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11564916 2029-08-13 U-4095 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11564916 2029-08-13 U-4466 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10081621 2031-03-25 U-4087 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10081621 2031-03-25 U-4468 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11578062 2031-03-25 U-4096 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11578062 2031-03-25 U-4465 Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 RE50453 2031-07-10 Drug substance, Drug product 2025-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 10047053 2032-05-17 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 8865902 2032-05-17 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9181192 2032-05-17 U-4094 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9181192 2032-05-17 U-4472 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9512079 2032-05-17 U-4098 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 9512079 2032-05-17 U-4471 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11066417 2039-02-14 Drug substance, Drug product 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218730-001 11866450 2039-02-14 U-4082 2025-01-17 84e616aacf4f…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ALYFTREK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANZACAFTOR 4 mg/1 TEZACAFTOR 20 mg/1 DEUTIVACAFTOR 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8RW88Y506K Internal UNII lookup COM1POP492 Internal UNII lookup SHA6U5FJZL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2701438 Internal RxNorm lookup 2701444 Internal RxNorm lookup 2701448 Internal RxNorm lookup 2701450 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 51167-135-01 ALYFTREK 21 in 1 BLISTER PACK TABLET, FILM COATED 21 8 51167-135-01 ALYFTREK 4 in 1 CARTON TABLET, FILM COATED 4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51167-135 ALYFTREK (VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED] 6 Current NDC, 2 package rows 20250205_7e635909-c6fd-4f0d-ae77-cdff03653a20.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALYFTREK VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR Vertex Pharmaceuticals Incorporated 7e635909-c6fd-4f0d-ae77-cdff03653a20 2026-08-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218730 application number: NDA218730 ndc (product): 51167-135
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51167-135-01 51167013501 4 BLISTER PACK in 1 CARTON (51167-135-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2024-12-20 No No Current