Home NDC 70518-2487-0 Temazepam
Product NDC 70518-2487
Requested package NDC 70518-2487-0
11-digit product format 705182487
Labeler code 70518
Product ID 70518-2487_4df349d4-cb93-33c8-e063-6394a90abeb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA071620
Marketing category ANDA
Marketing start 2019-12-16
Substance TEMAZEPAM
Active strength 15 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMAZEPAM 15 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 198241 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 70518-2487-0 Temazepam 100 in 1 BOX CAPSULE 100 13 70518-2487-1 Temazepam 1 in 1 POUCH CAPSULE 1 13 70518-2487-2 Temazepam 30 in 1 BLISTER PACK CAPSULE 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2487 TEMAZEPAM CAPSULE [REMEDYREPACK INC.] 9 Current NDC, Legacy NDC, 3 package rows 20250426_85919240-0bac-4ed9-97aa-f1aa29be7ffa.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 ndc (package): 70518-2487-0 ndc (product): 70518-2487 ndc11 (package): 70518248700 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
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 70518-2487-0 70518248700 100 POUCH in 1 BOX (70518-2487-0) > 1 CAPSULE in 1 POUCH (70518-2487-1) 100 pouch 2019-12-16 0000-00-00 No No Current