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 44 .
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 2026-10-15 13:18:30 2026-09 N215904-001 ZTALMY 50MG/ML SUSPENSION / ORAL RLD, RS 2022-06-01 c2088c7a36db…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 · 279 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N215904-001 7858609 2026-11-28 Drug product 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 8022054 2026-11-28 Drug product 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 8367651 2026-11-28 Drug product 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 8618087 2026-11-28 U-3374 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 9029355 2026-11-28 Drug product 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 9056116 2026-11-28 U-3374 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 8318714 2031-11-28 Drug product 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 10603308 2037-08-10 U-3374 2022-06-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 12144801 2037-08-10 U-4034 2024-11-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 12115169 2042-09-30 U-3374 2025-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215904-001 12268696 2042-09-30 U-3374 2025-10-29 c2088c7a36db…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…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 2 · 62 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
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