Home NDC 69616-264 AGAMREE
Product NDC 69616-264
11-digit product format 696160264
Labeler code 69616
Product ID 69616-264_8e502b8a-7d2d-476b-8516-6678cfefbe32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VAMOROLONE
Dosage form KIT
Route ORAL
Labeler Catalyst Pharmaceuticals, Inc.
Application NDA215239
Marketing category NDA
Marketing start 2024-02-01
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 42 .
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 N215239-001 AGAMREE VAMOROLONE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 N215239-001 12201639 2040-03-17 U-3747 Drug substance, Drug product 2025-02-14 N215239-001 11382922 2040-07-16 Drug substance, Drug product 2023-11-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215239-001 NCE 2028-10-26 N215239-001 ODE-450 2030-10-26
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 2026-08-18 06:07:40 2026-07 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215239-001 AGAMREE 40MG/ML SUSPENSION / ORAL RLD, RS 2023-10-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 119 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215239-001 12201639 2040-03-17 U-3747 Drug substance, Drug product 2025-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215239-001 11382922 2040-07-16 Drug substance, Drug product 2023-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215239-001 12201639 2040-03-17 U-3747 Drug substance, Drug product 2025-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215239-001 11382922 2040-07-16 Drug substance, Drug product 2023-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 12201639 2040-03-17 U-3747 Drug substance, Drug product 2025-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215239-001 11382922 2040-07-16 Drug substance, Drug product 2023-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215239-001 12201639 2040-03-17 U-3747 Drug substance, Drug product 2025-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215239-001 11382922 2040-07-16 Drug substance, Drug product 2023-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 12201639 2040-03-17 U-3747 Drug substance, Drug product 2025-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215239-001 11382922 2040-07-16 Drug substance, Drug product 2023-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215239-001 10857161 2029-05-28 U-3747 Drug product 2023-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215239-001 11833159 2029-05-28 Drug product 2023-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215239-001 8334279 2029-05-28 U-3747 2023-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215239-001 11690853 2033-03-07 U-3747 2023-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215239-001 11471471 2040-03-17 U-3747 2023-11-21 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base AGAMREE
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2669804 Internal RxNorm lookup 2669810 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 69616-264-38 AGAMREE 1 in 1 CARTON KIT 1 10 69616-265-38 AGAMREE 100 mL in 1 BOTTLE, GLASS SUSPENSION 100 mL 40 mg in 1mL 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69616-264 AGAMREE (VAMOROLONE) KIT [CATALYST PHARMACEUTICALS, INC.] 7 Current NDC, 2 package rows 20250413_fb376f09-cf9c-42b5-b4dd-02d5bcd73211.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 Sample Exclude flag Status 69616-264-38 69616026438 1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38) 1 kit 2024-02-01 No No Current 69616-265-38 69616026538 100 mL in 1 BOTTLE, GLASS 100 ml Historical