temazepam

Product NDC
70518-0647
11-digit product format
705180647
Labeler code
70518
Product ID
70518-0647_4d7512dc-aa35-33ea-e063-6394a90a28f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071456
Marketing category
ANDA
Marketing start
2017-07-28
Substance
TEMAZEPAM
Active strength
15 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

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 packagepackage70518-064770518-0647-1DDiscontinued 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 · 13 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0647-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0647-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0647-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0647-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0647-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0647-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0647-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0647-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0647-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0647-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0647-10efc9e666f02…f202fb6c5f17…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
temazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CHB1QD2QSSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198241Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
65857a9b-a225-4887-b0dc-58ab6d60f9d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0647-0temazepam30 in 1 BLISTER PACKCAPSULE3016
70518-0647-1temazepam100 in 1 BOXCAPSULE10016
70518-0647-2temazepam1 in 1 POUCHCAPSULE116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0647TEMAZEPAM CAPSULE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250429_65857a9b-a225-4887-b0dc-58ab6d60f9d0.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 · 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
ndc (product): 70518-0647
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN65857a9b-a225-4887-b0dc-58ab6d60f9d016
198241temazepam 15 MG Oral CapsuleSCD65857a9b-a225-4887-b0dc-58ab6d60f9d016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-0647-07051806470030 CAPSULE in 1 BLISTER PACK (70518-0647-0) 30 capsule2017-07-28NoNoCurrent
70518-0647-170518064701100 in 1 BOXHistorical
70518-0647-2705180647021 in 1 POUCHHistorical