Home NDC 43353-711 Temazepam
Product NDC 43353-711
11-digit product format 433530711
Labeler code 43353
Product ID 43353-711_7d55fc67-1183-48fe-b6f6-a9cbc1df0d25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name temazepam
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA070920
Marketing category ANDA
Marketing start 2012-10-25
Marketing end 0000-00-00
Substance TEMAZEPAM
Active strength 8 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A070920-001 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 A070920-002 TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 A070920-003 TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 A070920-004 TEMAZEPAM TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07
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 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070920-001 TEMAZEPAM 30MG CAPSULE / ORAL 1986-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070920-002 TEMAZEPAM 7.5MG CAPSULE / ORAL 2010-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070920-003 TEMAZEPAM 22.5MG CAPSULE / ORAL 2009-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070920-004 TEMAZEPAM 15MG CAPSULE / ORAL 1986-07-07 d06236e962d9…
Observed Orange Book normalized TE history# 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 43353-711-30 Temazepam 30 in 1 BOTTLE, PLASTIC CAPSULE 30 2 43353-711-53 Temazepam 60 in 1 BOTTLE, PLASTIC CAPSULE 60 2 43353-711-60 Temazepam 90 in 1 BOTTLE, PLASTIC CAPSULE 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-711 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 3 package rows 20140415_4ac590e9-af71-43c0-a836-b700115d7ba2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-711-30 43353071130 30 in 1 BOTTLE, PLASTIC Historical 43353-711-53 43353071153 60 in 1 BOTTLE, PLASTIC Historical 43353-711-60 43353071160 90 in 1 BOTTLE, PLASTIC Historical