Home NDC 52427-775 zolpidem tartrate
Product NDC 52427-775
11-digit product format 524270775
Labeler code 52427
Product ID 52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419dae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form CAPSULE
Route ORAL
Labeler Almatica Pharma LLC
Application NDA215721
Marketing category NDA
Marketing start 2023-05-09
Substance ZOLPIDEM TARTRATE
Active strength 7.5 mg/1
Pharmacologic classes Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule CIV
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 1 .
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 N215721-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB RLD, RS 2023-05-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215721-001 AB
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 2026-02-19 14:30 UTC 2026-02 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL RLD, RS 2023-05-09 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB RLD, RS 2023-05-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215721-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base zolpidem tartrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLPIDEM TARTRATE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WY6W63843K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637353 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 52427-775-30 zolpidem tartrate 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-775 ZOLPIDEM TARTRATE CAPSULE [ALMATICA PHARMA LLC] 2 Current NDC, 1 package rows 20241016_2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52427-775-30 52427077530 30 CAPSULE in 1 BOTTLE (52427-775-30) 30 capsule 2023-05-24 No No Current