temazepam

Product NDC
63629-1054
Requested package NDC
63629-1054-1
11-digit product format
636291054
Labeler code
63629
Product ID
63629-1054_cc54037f-7bde-434b-979e-636aa1b4951b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071456
Marketing category
ANDA
Marketing start
1987-04-21
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
15 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-105463629-1054-1DDiscontinued by firm2026-08-07

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071456-001TEMAZEPAMTEMAZEPAM15MGCAPSULE / ORALAB1987-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071456-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-213f01610625f2…
2019-09-15 20:21 UTC2019-09A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071456-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071456-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071456-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071456-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071456-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071456-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071456-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071456-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071456-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071456-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071456-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071456-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071456-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071456-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071456-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071456-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071456-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071456-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071456-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071456-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071456-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071456-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071456-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071456-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071456-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071456-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071456-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071456-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071456-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071456-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071456-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071456-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071456-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071456-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071456-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071456-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071456-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071456-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071456-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071456-001AB1cb3db0bc1861…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
temazepamTEMAZEPAMAscend Laboratories, LLC8f54731f-c5b7-492c-acb0-444c5fbb70292026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMREMEDYREPACK INC.65857a9b-a225-4887-b0dc-58ab6d60f9d02026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMBryant Ranch Prepacka1f0ed55-9401-4afe-ba98-1ca115ba86b52025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMA-S Medication Solutions19b2711e-587a-47d2-ab62-d564e7b871952025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMPD-Rx Pharmaceuticals, Inc.45ef5e9c-f381-48d3-895d-e1d29be856ac2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMAsclemed USA, Inc.254a0273-c0f3-4d2d-b18e-4ab51ba4bc502025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMPreferred Pharmaceuticals Inc.42b81d6f-8171-4cd0-ab79-f031a8254d652025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMAvPAK08183adb-af12-fcb2-e063-6394a90afea42025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
TemazepamTEMAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCd83e14ae-9823-e57b-e053-2a95a90a85242024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
TemazepamTEMAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCf885bb1a-0445-c452-e053-6394a90ae8aa2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMBryant Ranch Prepacka90d9165-da54-48e5-b144-ebeb6ff8d8ab2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMBryant Ranch Prepackac08a51c-6c54-40da-9626-a4c82f337a3a2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMBryant Ranch Prepack432252c6-648f-4c53-976c-ee271ba435bd2024-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMAphena Pharma Solutions - Tennessee, LLCb2422ca0-2f06-419f-aa0e-88c556b623992024-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMBryant Ranch Prepack5dc0c671-3cd8-4e75-9e76-19c1c17b30b22023-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMProficient Rx LP904b8986-24da-48eb-bb0a-33d41b4eb0052023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456
temazepamTEMAZEPAMProficient Rx LPccf04879-3ad5-4fc3-89f5-879c978870172022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071456
application number: ANDA071456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1054-16362910540115 CAPSULE in 1 BOTTLE (63629-1054-1) 15 capsule2022-06-220000-00-00NoNoCurrent