Home NDC 73625-112 CAMZYOS
Product NDC 73625-112
11-digit product format 736250112
Labeler code 73625
Product ID 73625-112_85338960-904b-44df-908f-b74b62902779
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mavacamten
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Myokardia, Inc.
Application NDA214998
Marketing category NDA
Marketing start 2022-04-28
Substance MAVACAMTEN
Active strength 5 mg/1
Pharmacologic classes Cardiac Myosin Inhibitor [EPC], Cardiac Myosin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214998-001 CAMZYOS MAVACAMTEN 2.5MG CAPSULE / ORAL RLD 2022-04-28 N214998-002 CAMZYOS MAVACAMTEN 5MG CAPSULE / ORAL RLD, RS 2022-04-28 N214998-003 CAMZYOS MAVACAMTEN 10MG CAPSULE / ORAL RLD 2022-04-28 N214998-004 CAMZYOS MAVACAMTEN 15MG CAPSULE / ORAL RLD 2022-04-28
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214998-001 9585883 2034-06-19 U-3373 2022-05-26 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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.
Product history page 1 of 4 · 124 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 2026-09-14 22:38:34 2026-08 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 7 · 248 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 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-001 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-002 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-003 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-004 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 312 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CAMZYOS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAVACAMTEN 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QX45B99R3J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2600872 Internal RxNorm lookup 2600878 Internal RxNorm lookup 2600880 Internal RxNorm lookup 2600882 Internal RxNorm lookup 2600884 Internal RxNorm lookup 2600886 Internal RxNorm lookup 2600888 Internal RxNorm lookup 2600890 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 73625-112-11 CAMZYOS 30 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73625-112 CAMZYOS (MAVACAMTEN) CAPSULE, GELATIN COATED [MYOKARDIA, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250501_669c936b-3ee6-4e36-8a22-79dd11b1255b.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 Marketing start Marketing end Sample Exclude flag Status 73625-112-11 73625011211 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-112-11) 2022-04-28 0000-00-00 No No Current