Home NDC 52427-775 zolpidem tartrate
Product NDC 52427-775
11-digit product format 524270775
Labeler code 52427
Product ID 52427-775_8f5a9e19-eeab-e516-887b-ade5d40cbd6c
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB RLD, RS 2023-05-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB RLD, RS 2023-05-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215721-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB RLD, RS 2023-05-09 caaa826d4ba7…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# 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 zolpidem tartrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLPIDEM TARTRATE 7.5 mg/1
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
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