Home NDC 68788-7208 zaleplon
Product NDC 68788-7208
11-digit product format 687887208
Labeler code 68788
Product ID 68788-7208_4a57b226-0677-4ef4-a0fd-12f2342f12e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zaleplon
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA078989
Marketing category ANDA
Marketing start 2018-08-06
Substance ZALEPLON
Active strength 10 mg/1
Pharmacologic classes Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA schedule CIV
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 45 .
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 A078989-001 ZALEPLON ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 A078989-002 ZALEPLON ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 90 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 2026-11-14 07:37:17 2026-10 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 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 zaleplon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZALEPLON 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S62U433RMH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313761 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 68788-7208-1 zaleplon 100 in 1 BOTTLE, PLASTIC CAPSULE 100 8 68788-7208-2 zaleplon 20 in 1 BOTTLE, PLASTIC CAPSULE 20 8 68788-7208-3 zaleplon 30 in 1 BOTTLE, PLASTIC CAPSULE 30 8 68788-7208-6 zaleplon 60 in 1 BOTTLE, PLASTIC CAPSULE 60 8 68788-7208-9 zaleplon 90 in 1 BOTTLE, PLASTIC CAPSULE 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7208 ZALEPLON CAPSULE [PREFERRED PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 5 package rows 20240906_b0476859-07af-47f1-aec7-61aea0d99d24.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join zaleplon ZALEPLON PD-Rx Pharmaceuticals, Inc. 2cc7adee-2c4c-4fed-9914-545e70dba773 2025-10-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON A-S Medication Solutions 8276a418-6a4c-4b81-8170-2d3838576c6d 2024-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON Bryant Ranch Prepack d8c88122-ce04-4caf-bd4d-0a4368ea89ad 2023-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON Bryant Ranch Prepack b8032b14-5068-19d5-e063-839ed25d7200 2023-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON Unichem Pharmaceuticals (USA), Inc. 57a1a11d-7767-4caf-b98a-75d7561d9165 2021-06-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989
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 68788-7208-1 68788720801 100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-1) 100 capsule 2018-08-06 0000-00-00 No No Current 68788-7208-2 68788720802 20 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-2) 20 capsule 2018-08-06 0000-00-00 No No Current 68788-7208-3 68788720803 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-3) 30 capsule 2018-08-06 0000-00-00 No No Current 68788-7208-6 68788720806 60 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-6) 60 capsule 2018-08-06 0000-00-00 No No Current 68788-7208-9 68788720809 90 CAPSULE in 1 BOTTLE, PLASTIC (68788-7208-9) 90 capsule 2018-08-06 0000-00-00 No No Current