Home NDC 72028-045 Wakix
Product NDC 72028-045
11-digit product format 720280045
Labeler code 72028
Product ID 72028-045_377224a0-fa6e-498f-b42e-9f8d191728e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PITOLISANT HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Harmony Biosciences, LLC
Application NDA211150
Marketing category NDA
Marketing start 2019-08-14
Substance PITOLISANT HYDROCHLORIDE
Active strength 4.45 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inducers [MoA], Histamine H3 Receptor Antagonists [MoA], Histamine H3 Receptor Inverse Agonists [MoA], Histamine-3 Receptor Antagonist/Inverse Agonist [EPC]
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 N211150-001 WAKIX PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE TABLET / ORAL AB RLD 2019-08-14 N211150-002 WAKIX PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE TABLET / ORAL AB RLD, RS 2019-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211150-001 8354430 2026-02-06 U-1101 2019-09-11 N211150-001 8354430 2026-02-06 U-1102 2019-09-11 N211150-001 8486947 2029-09-26 U-1101 2019-09-11 N211150-001 8486947 2029-09-26 U-1102 2019-09-11 N211150-001 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 N211150-002 8354430 2026-02-06 U-1101 2019-09-11 N211150-002 8354430 2026-02-06 U-1102 2019-09-11 N211150-002 8486947 2029-09-26 U-1101 2019-09-11 N211150-002 8486947 2029-09-26 U-1102 2019-09-11 N211150-002 8207197 2030-03-07 Drug substance, Drug product 2019-09-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 10 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 3 · 84 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 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL AB RLD 2019-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL AB RLD, RS 2019-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL AB RLD 2019-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL AB RLD, RS 2019-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211150-001 WAKIX EQ 4.45MG BASE TABLET / ORAL RLD 2019-08-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N211150-002 WAKIX EQ 17.8MG BASE TABLET / ORAL RLD, RS 2019-08-14 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 420 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 N211150-001 8354430 2026-02-06 U-1101 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-001 8354430 2026-02-06 U-1102 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-001 8486947 2029-09-26 U-1101 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-001 8486947 2029-09-26 U-1102 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-001 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-002 8354430 2026-02-06 U-1101 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-002 8354430 2026-02-06 U-1102 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-002 8486947 2029-09-26 U-1101 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-002 8486947 2029-09-26 U-1102 2019-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211150-002 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211150-001 8354430 2026-02-06 U-1101 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-001 8354430 2026-02-06 U-1102 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-001 8486947 2029-09-26 U-1101 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-001 8486947 2029-09-26 U-1102 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-001 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-002 8354430 2026-02-06 U-1101 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-002 8354430 2026-02-06 U-1102 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-002 8486947 2029-09-26 U-1101 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-002 8486947 2029-09-26 U-1102 2019-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211150-002 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211150-001 8354430 2026-02-06 U-1101 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-001 8354430 2026-02-06 U-1102 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-001 8486947 2029-09-26 U-1101 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-001 8486947 2029-09-26 U-1102 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-001 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-002 8354430 2026-02-06 U-1101 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-002 8354430 2026-02-06 U-1102 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-002 8486947 2029-09-26 U-1101 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-002 8486947 2029-09-26 U-1102 2019-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211150-002 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-001 8354430 2026-02-06 U-1101 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-001 8354430 2026-02-06 U-1102 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-001 8486947 2029-09-26 U-1101 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-001 8486947 2029-09-26 U-1102 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-001 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-002 8354430 2026-02-06 U-1101 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-002 8354430 2026-02-06 U-1102 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-002 8486947 2029-09-26 U-1101 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-002 8486947 2029-09-26 U-1102 2019-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211150-002 8207197 2030-03-07 Drug substance, Drug product 2019-09-11 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 318 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 Wakix
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PITOLISANT HYDROCHLORIDE 4.45 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YV33CH63HI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2197884 Internal RxNorm lookup 2197890 Internal RxNorm lookup 2197892 Internal RxNorm lookup 2197894 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 72028-045-03 Wakix 1 in 1 CARTON TABLET, FILM COATED 1 18 72028-045-03 Wakix 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72028-045 WAKIX (PITOLISANT HYDROCHLORIDE) TABLET, FILM COATED [HARMONY BIOSCIENCES, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20250515_8daa5562-824e-476c-9652-26ceef3d4b0e.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 Wakix PITOLISANT HYDROCHLORIDE Harmony Biosciences, LLC 8daa5562-824e-476c-9652-26ceef3d4b0e 2026-02-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 211150 application number: NDA211150 ndc (product): 72028-045
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 72028-045-03 72028004503 1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2019-08-14 0000-00-00 No No Current