Home NDC 53489-648-10 Temazepam
Product NDC 53489-648
Requested package NDC 53489-648-10
11-digit product format 534890648
Labeler code 53489
Product ID 53489-648_4eeff7a1-a4af-41ac-98cf-2790d40c91df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078581
Marketing category ANDA
Marketing start 2009-09-09
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 2020-12-31
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 · 8 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078581-001 TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE / ORAL 2009-09-08
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2009-09-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2009-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2009-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2009-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL 2009-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078581-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2009-09-08 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Temazepam ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 Temazepam ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 D&C yellow NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 FD&C blue NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 FD&C blue NO. 2 INACTIVE INGREDIENT L06K8R7DQK TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 FD&C red NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 FD&C Yellow NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 gelatin INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [MUTUAL PHARMACEUTICAL COMPANY, INC.] 6 Temazepam ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 Temazepam ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 D&C yellow NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 FD&C blue NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 FD&C blue NO. 2 INACTIVE INGREDIENT L06K8R7DQK TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 FD&C red NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM (TEMAZEPAM) CAPSULE [AVKARE, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53489-648-10 53489064810 1000 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-10) 1000 capsule 2009-09-09 0000-00-00 No No Current