Home NDC 61919-438-30 TEMAZEPAM
Product NDC 61919-438
Requested package NDC 61919-438-30
11-digit product format 619190438
Labeler code 61919
Product ID 61919-438_f2140c0c-7b2e-2096-e053-2995a90ad56e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TEMAZEPAM
Dosage form CAPSULE
Route ORAL
Labeler Direct Rx
Application ANDA071620
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance TEMAZEPAM
Active strength 30 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
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 61919-438-30 TEMAZEPAM 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-438 TEMAZEPAM CAPSULE [DIRECT RX] 5 Legacy NDC, 1 package rows 20230422_5de3751c-66d8-4b77-8698-12b67aa5f9e8.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
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 61919-438-30 61919043830 30 CAPSULE in 1 BOTTLE (61919-438-30) 30 capsule 2015-01-01 0000-00-00 No No Current