Home NDC 68727-150 XYWAV
Product NDC 68727-150
11-digit product format 687270150
Labeler code 68727
Product ID 68727-150_6815ce2b-51e5-4d03-92a6-523718ab0d8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcium, magnesium, potassium, and sodium oxybates
Dosage form SOLUTION
Route ORAL
Labeler Jazz Pharmaceuticals, Inc.
Application NDA212690
Marketing category NDA
Marketing start 2020-11-02
Substance SODIUM OXYBATE; CALCIUM OXYBATE; POTASSIUM OXYBATE; MAGNESIUM OXYBATE
Active strength .5; .5; .5; .5 g/mL; g/mL; g/mL; g/mL
Pharmacologic classes Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [PE]
DEA schedule CIII
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212690-001 XYWAV CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21
Orange Book patents# Current patent rows page 1 of 1 · 25 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212690-001 ODE-361 2027-07-21 N212690-001 PED 2028-01-21 N212690-001 ODE-369 2028-08-12
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 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212690-001 XYWAV 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML SOLUTION / ORAL RLD, RS 2020-07-21 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 20 · 782 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 130 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 XYWAV
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM OXYBATE .5 g/mL CALCIUM OXYBATE .5 g/mL POTASSIUM OXYBATE .5 g/mL MAGNESIUM OXYBATE .5 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2393794 Internal RxNorm lookup 2393795 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 68727-150-01 XYWAV 180 mL in 1 BOTTLE, PLASTIC SOLUTION 180 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68727-150 XYWAV (CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES) SOLUTION [JAZZ PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20241010_1e0ae43a-037f-42af-8e23-a0e51d75abe8.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 XYWAV CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES Jazz Pharmaceuticals, Inc. 1e0ae43a-037f-42af-8e23-a0e51d75abe8 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212690 application number: NDA212690 ndc (product): 68727-150
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68727-150-01 68727015001 180 mL in 1 BOTTLE, PLASTIC (68727-150-01) 180 ml 2020-11-02 0000-00-00 No No Current