Home NDC 0037-6050-93 Edluar
Product NDC 0037-6050
Requested package NDC 0037-6050-93
11-digit product format 000376050
Labeler code 0037
Product ID 0037-6050_f9d32621-9e2f-4dbf-8189-c5ab3168b5d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolpidem Tartrate
Dosage form TABLET
Route ORAL
Labeler Viatris Specialty LLC
Application NDA021997
Marketing category NDA
Marketing start 2009-07-24
Substance ZOLPIDEM TARTRATE
Active strength 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 43 .
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 N021997-001 EDLUAR ZOLPIDEM TARTRATE 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 N021997-002 EDLUAR ZOLPIDEM TARTRATE 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021997-001 9597281 2027-04-06 U-674 2017-04-07 N021997-001 9265720 2031-02-25 U-674 2016-03-18 N021997-002 9597281 2027-04-06 U-674 2017-04-07 N021997-002 9265720 2031-02-25 U-674 2016-03-18
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 · 86 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 2026-09-14 22:38:34 2026-08 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 188 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021997-001 9597281 2027-04-06 U-674 2017-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021997-001 9265720 2031-02-25 U-674 2016-03-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021997-002 9597281 2027-04-06 U-674 2017-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021997-002 9265720 2031-02-25 U-674 2016-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021997-001 9597281 2027-04-06 U-674 2017-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021997-001 9265720 2031-02-25 U-674 2016-03-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021997-002 9597281 2027-04-06 U-674 2017-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021997-002 9265720 2031-02-25 U-674 2016-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021997-001 9597281 2027-04-06 U-674 2017-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-001 9265720 2031-02-25 U-674 2016-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-002 9597281 2027-04-06 U-674 2017-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-002 9265720 2031-02-25 U-674 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-001 9597281 2027-04-06 U-674 2017-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-001 9265720 2031-02-25 U-674 2016-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-002 9597281 2027-04-06 U-674 2017-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-002 9265720 2031-02-25 U-674 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021997-001 9597281 2027-04-06 U-674 2017-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-001 9265720 2031-02-25 U-674 2016-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-002 9597281 2027-04-06 U-674 2017-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-002 9265720 2031-02-25 U-674 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-001 9597281 2027-04-06 U-674 2017-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-001 9265720 2031-02-25 U-674 2016-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-002 9597281 2027-04-06 U-674 2017-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-002 9265720 2031-02-25 U-674 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-001 9597281 2027-04-06 U-674 2017-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-001 9265720 2031-02-25 U-674 2016-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-002 9597281 2027-04-06 U-674 2017-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-002 9265720 2031-02-25 U-674 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-001 9597281 2027-04-06 U-674 2017-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-001 9265720 2031-02-25 U-674 2016-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-002 9597281 2027-04-06 U-674 2017-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-002 9265720 2031-02-25 U-674 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-001 9597281 2027-04-06 U-674 2017-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-001 9265720 2031-02-25 U-674 2016-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-002 9597281 2027-04-06 U-674 2017-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-002 9265720 2031-02-25 U-674 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-001 9597281 2027-04-06 U-674 2017-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-001 9265720 2031-02-25 U-674 2016-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-002 9597281 2027-04-06 U-674 2017-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-002 9265720 2031-02-25 U-674 2016-03-18 5bbf6a4d5a75…
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 Edluar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLPIDEM TARTRATE 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 836641 Internal RxNorm lookup 836645 Internal RxNorm lookup 836647 Internal RxNorm lookup 836649 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0037-6050-35 Edluar 6 in 1 BLISTER PACK TABLET 6 22 0037-6050-93 Edluar 5 in 1 CARTON TABLET 5 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0037-6050 EDLUAR (ZOLPIDEM TARTRATE) TABLET [MEDA PHARMACEUTICALS INC.] 20 Current NDC, Legacy NDC, 2 package rows 20221004_a32884d0-85b5-11de-8a39-0800200c9a66.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 Marketing end Sample Exclude flag Status 0037-6050-93 00037605093 5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35) 5 blister pack 2022-02-16 0000-00-00 No No Current