Home NDC 68071-4083 Temazepam
Product NDC 68071-4083
11-digit product format 680714083
Labeler code 68071
Product ID 68071-4083_1d8e1fca-6862-7c08-e063-6394a90a08b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam CIV
Dosage form CAPSULE
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA071620
Marketing category ANDA
Marketing start 1990-09-30
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-4083-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4083-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4083-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4083-3 1332a3947898…d4bfe170f9cd…
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 A071620-001 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 A071620-002 TEMAZEPAM TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07
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 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4083-3 Temazepam 30 in 1 BOTTLE CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4083 TEMAZEPAM (TEMAZEPAM CIV) CAPSULE [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240727_617d1957-c414-7f34-e053-2a91aa0a3fe0.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Temazepam TEMAZEPAM REMEDYREPACK INC. 85919240-0bac-4ed9-97aa-f1aa29be7ffa 2026-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 Temazepam TEMAZEPAM Bryant Ranch Prepack 38afa73c-7c87-440d-bece-f268e8e4a44c 2025-03-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 Temazepam TEMAZEPAM Actavis Pharma, Inc. a4370eb4-b00d-4247-af8d-980e59fbbec6 2025-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 Temazepam TEMAZEPAM CIV NuCare Pharmaceuticals,Inc. 617d1957-c414-7f34-e053-2a91aa0a3fe0 2024-07-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 ndc (product): 68071-4083
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 68071-4083-3 68071408303 30 CAPSULE in 1 BOTTLE (68071-4083-3) 30 capsule 2017-12-29 0000-00-00 No No Current