Home NDC 71335-1901 Temazepam
Product NDC 71335-1901
11-digit product format 713351901
Labeler code 71335
Product ID 71335-1901_aab3930e-3d41-4abe-93c2-4cd07740050d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA203482
Marketing category ANDA
Marketing start 2016-05-23
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198242 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1901 TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 9 package rows 20241225_066e25b2-8a1b-4b08-b585-ce36753bf104.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 Marketing end Sample Exclude flag Status 71335-1901-1 71335190101 30 CAPSULE in 1 BOTTLE (71335-1901-1) 30 capsule 2021-07-15 0000-00-00 No No Current 71335-1901-2 71335190102 20 CAPSULE in 1 BOTTLE (71335-1901-2) 20 capsule 2024-12-11 0000-00-00 No No Current 71335-1901-3 71335190103 100 CAPSULE in 1 BOTTLE (71335-1901-3) 100 capsule 2024-12-11 0000-00-00 No No Current 71335-1901-4 71335190104 60 CAPSULE in 1 BOTTLE (71335-1901-4) 60 capsule 2021-08-26 0000-00-00 No No Current 71335-1901-5 71335190105 90 CAPSULE in 1 BOTTLE (71335-1901-5) 90 capsule 2021-11-03 0000-00-00 No No Current 71335-1901-6 71335190106 28 CAPSULE in 1 BOTTLE (71335-1901-6) 28 capsule 2024-12-11 0000-00-00 No No Current 71335-1901-7 71335190107 10 CAPSULE in 1 BOTTLE (71335-1901-7) 10 capsule 2024-12-11 0000-00-00 No No Current 71335-1901-8 71335190108 45 CAPSULE in 1 BOTTLE (71335-1901-8) 45 capsule 2024-12-11 0000-00-00 No No Current 71335-1901-9 71335190109 120 CAPSULE in 1 BOTTLE (71335-1901-9) 120 capsule 2024-12-11 0000-00-00 No No Current