Home NDC 67877-149 temazepam
Product NDC 67877-149
11-digit product format 678770149
Labeler code 67877
Product ID 67877-149_23e08cbc-80d4-4938-8d56-10e7682b5336
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name temazepam
Dosage form CAPSULE
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA071457
Marketing category ANDA
Marketing start 2012-06-28
Substance TEMAZEPAM
Active strength 22.5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071457-001 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 A071457-002 TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 A071457-003 TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base temazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMAZEPAM 22.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198241 Internal RxNorm lookup 198242 Internal RxNorm lookup 198243 Internal RxNorm lookup 485489 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 67877-149-01 temazepam 100 in 1 BOTTLE CAPSULE 100 14 67877-149-05 temazepam 500 in 1 BOTTLE CAPSULE 500 14 67877-149-30 temazepam 30 in 1 BOTTLE CAPSULE 30 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded temazepam ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 temazepam ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 alcohol INACTIVE INGREDIENT 3K9958V90M TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 ammonia INACTIVE INGREDIENT 5138Q19F1X TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 gelatin INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 shellac INACTIVE INGREDIENT 46N107B71O TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 starch, corn INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 3945 temazepam ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 temazepam ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 alcohol INACTIVE INGREDIENT 3K9958V90M TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 ammonia INACTIVE INGREDIENT 5138Q19F1X TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 gelatin INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 shellac INACTIVE INGREDIENT 46N107B71O TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 starch, corn INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 10 temazepam ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 temazepam ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-149 TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC] 14 Current NDC, Legacy NDC, 3 package rows 20231227_8f54731f-c5b7-492c-acb0-444c5fbb7029.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 2 of 2 · 23 matching rows.
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 67877-149-01 67877014901 100 CAPSULE in 1 BOTTLE (67877-149-01) 100 capsule 2012-06-28 0000-00-00 No No Current 67877-149-05 67877014905 500 CAPSULE in 1 BOTTLE (67877-149-05) 500 capsule 2012-06-28 0000-00-00 No No Current 67877-149-30 67877014930 30 CAPSULE in 1 BOTTLE (67877-149-30) 30 capsule 2012-06-28 0000-00-00 No No Current