Home NDC 0713-5401 Ambien
Product NDC 0713-5401
11-digit product format 007135401
Labeler code 0713
Product ID 0713-5401_2d934208-e709-2948-e063-6294a90aa9b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA019908
Marketing category NDA
Marketing start 2025-02-07
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 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 N019908-001 AMBIEN ZOLPIDEM TARTRATE 5MG TABLET / ORAL AB RLD 1992-12-16 N019908-002 AMBIEN ZOLPIDEM TARTRATE 10MG TABLET / ORAL AB RLD, RS 1992-12-16
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 · 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 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019908-001 AMBIEN 5MG TABLET / ORAL AB RLD 1992-12-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019908-002 AMBIEN 10MG TABLET / ORAL AB RLD, RS 1992-12-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ambien
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 854873 Internal RxNorm lookup 854875 Internal RxNorm lookup 854876 Internal RxNorm lookup 854878 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 0713-5401-01 Ambien 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-5401 AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250210_747949c5-2c91-4909-8a07-71b6826f8e97.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0713-5401-01 00713540101 100 TABLET, FILM COATED in 1 BOTTLE (0713-5401-01) 2025-02-07 No No Current