Home NDC 21695-376 ZALEPLON
Product NDC 21695-376
11-digit product format 216950376
Labeler code 21695
Product ID 21695-376_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ZALEPLON
Dosage form CAPSULE
Route ORAL
Labeler Rebel Distributors Corp.
Application NDA020859
Marketing category NDA
Marketing start 2008-05-01
Marketing end 0000-00-00
Substance ZALEPLON
Active strength 5 mg/1
Pharmacologic classes gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
DEA schedule CIV
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21695-376-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 21695-376-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 21695-376-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 21695-376-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 21695-376-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 21695-376-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 21695-376-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 21695-376-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 21695-376-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 21695-376-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 21695-376-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 21695-376-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-376-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-376-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-376-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-376-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-376-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-376-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-376-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-376-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-376-60 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-376-60 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020859-001 SONATA ZALEPLON 5MG CAPSULE / ORAL RLD 1999-08-13 N020859-002 SONATA ZALEPLON 10MG CAPSULE / ORAL RLD 1999-08-13
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N020859-001 SONATA 5MG CAPSULE / ORAL RLD 1999-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020859-002 SONATA 10MG CAPSULE / ORAL RLD 1999-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020859-001 SONATA 5MG CAPSULE / ORAL RLD 1999-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020859-002 SONATA 10MG CAPSULE / ORAL RLD 1999-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020859-001 SONATA 5MG CAPSULE / ORAL AB RLD 1999-08-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020859-002 SONATA 10MG CAPSULE / ORAL AB RLD, RS 1999-08-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients#