Home NDC 81583-100-01 ZTALMY
Product NDC 81583-100
Requested package NDC 81583-100-01
11-digit product format 815830100
Labeler code 81583
Product ID 81583-100_7733b399-cf1c-4408-9825-87d4875f5332
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ganaxolone
Dosage form SUSPENSION
Route ORAL
Labeler Immedica Pharma US Inc
Application NDA215904
Marketing category NDA
Marketing start 2022-06-06
Substance GANAXOLONE
Active strength 50 mg/mL
Pharmacologic classes GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule CV
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215904-001 ZTALMY GANAXOLONE 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215904-001 7858609 2026-11-28 Drug product 2022-06-02 N215904-001 8022054 2026-11-28 Drug product 2022-06-02 N215904-001 8367651 2026-11-28 Drug product 2022-06-02 N215904-001 8618087 2026-11-28 U-3374 2022-06-02 N215904-001 9029355 2026-11-28 Drug product 2022-06-02 N215904-001 9056116 2026-11-28 U-3374 2022-06-02 N215904-001 8318714 2031-11-28 Drug product 2022-06-02 N215904-001 10603308 2037-08-10 U-3374 2022-06-02 N215904-001 12144801 2037-08-10 U-4034 2024-11-21 N215904-001 12115169 2042-09-30 U-3374 2025-10-29 N215904-001 12268696 2042-09-30 U-3374 2025-10-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215904-001 NCE 2027-06-01 N215904-001 D-197 2028-10-16 N215904-001 ODE-395 2029-06-01
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 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 268 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 N215904-001 7858609 2026-11-28 Drug product 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 8022054 2026-11-28 Drug product 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 8367651 2026-11-28 Drug product 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 8618087 2026-11-28 U-3374 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 9029355 2026-11-28 Drug product 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 9056116 2026-11-28 U-3374 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 8318714 2031-11-28 Drug product 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 10603308 2037-08-10 U-3374 2022-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 12144801 2037-08-10 U-4034 2024-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 12115169 2042-09-30 U-3374 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215904-001 12268696 2042-09-30 U-3374 2025-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215904-001 7858609 2026-11-28 Drug product 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 8022054 2026-11-28 Drug product 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 8367651 2026-11-28 Drug product 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 8618087 2026-11-28 U-3374 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 9029355 2026-11-28 Drug product 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 9056116 2026-11-28 U-3374 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 8318714 2031-11-28 Drug product 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 10603308 2037-08-10 U-3374 2022-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 12144801 2037-08-10 U-4034 2024-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 12115169 2042-09-30 U-3374 2025-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215904-001 12268696 2042-09-30 U-3374 2025-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215904-001 7858609 2026-11-28 Drug product 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 8022054 2026-11-28 Drug product 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 8318714 2026-11-28 Drug product 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 8367651 2026-11-28 Drug product 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 8618087 2026-11-28 U-3374 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 9029355 2026-11-28 Drug product 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 9056116 2026-11-28 U-3374 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 10603308 2037-08-10 U-3374 2022-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 12144801 2037-08-10 U-4034 2024-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 12115169 2042-09-30 U-3374 2025-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215904-001 12268696 2042-09-30 U-3374 2025-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 7858609 2026-11-28 Drug product 2022-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 8022054 2026-11-28 Drug product 2022-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 8318714 2026-11-28 Drug product 2022-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 8367651 2026-11-28 Drug product 2022-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 8618087 2026-11-28 U-3374 2022-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 9029355 2026-11-28 Drug product 2022-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215904-001 9056116 2026-11-28 U-3374 2022-06-02 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 59 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ZTALMY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GANAXOLONE 50 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81583-100-01 ZTALMY 1 in 1 CARTON SUSPENSION 1 13 81583-100-01 ZTALMY 110 mL in 1 BOTTLE, PLASTIC SUSPENSION 110 13 81583-100-05 ZTALMY 110 mL in 1 BOTTLE, PLASTIC SUSPENSION 110 13 81583-100-05 ZTALMY 5 in 1 CARTON SUSPENSION 5 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81583-100 ZTALMY (GANAXOLONE) SUSPENSION [IMMEDICA PHARMA US INC] 9 Current NDC, Legacy NDC, 4 package rows 20250521_d91612c4-b03a-4be4-a1ee-6a13e3b83d4e.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 81583-100-01 81583010001 1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC 2022-06-06 0000-00-00 No No Current