Home NDC 53746-557 Temazepam
Product NDC 53746-557
11-digit product format 537460557
Labeler code 53746
Product ID 53746-557_18d70b19-ff94-443e-8169-cb7e87895146
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA203482
Marketing category ANDA
Marketing start 2024-02-19
Substance TEMAZEPAM
Active strength 30 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203482-001 TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2016-05-23 A203482-002 TEMAZEPAM TEMAZEPAM 15MG CAPSULE / ORAL AB 2016-05-23 A203482-003 TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2016-05-23 A203482-004 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 2016-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2016-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2016-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2016-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2016-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2016-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2016-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2016-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2016-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2016-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL 2016-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2016-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL 2016-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203482-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2016-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203482-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2016-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203482-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2016-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203482-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2016-05-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Temazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMAZEPAM 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CHB1QD2QSS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198241 Internal RxNorm lookup 198242 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 53746-557-01 Temazepam 100 in 1 BOTTLE CAPSULE 100 1 53746-557-05 Temazepam 500 in 1 BOTTLE CAPSULE 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-557 TEMAZEPAM CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 1 Current NDC, 2 package rows 20240220_6248295e-8176-48f8-8e9d-bba6deacaf0d.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 · 3 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 53746-557-01 53746055701 100 CAPSULE in 1 BOTTLE (53746-557-01) 100 capsule 2024-02-19 No No Current 53746-557-05 53746055705 500 CAPSULE in 1 BOTTLE (53746-557-05) 500 capsule 2024-02-19 No No Current