temazepam

Product NDC
43353-312
11-digit product format
433530312
Labeler code
43353
Product ID
43353-312_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071456
Marketing category
ANDA
Marketing start
1987-04-21
Substance
TEMAZEPAM
Active strength
15 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071456-001TEMAZEPAM15MGCAPSULE / ORALAB1987-04-21caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071456-001AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
temazepam
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198241Internal RxNorm lookup
198242Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2422ca0-2f06-419f-aa0e-88c556b62399Available 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
43353-312-10temazepam10 in 1 BOTTLECAPSULE104
43353-312-15temazepam15 in 1 BOTTLECAPSULE154
43353-312-28temazepam28 in 1 BOTTLECAPSULE284
43353-312-30temazepam30 in 1 BOTTLECAPSULE304
43353-312-45temazepam45 in 1 BOTTLECAPSULE454
43353-312-53temazepam60 in 1 BOTTLECAPSULE604
43353-312-60temazepam90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-312-10EA - Each43353-31268b27f60-e2b3-419e-938f-4677089391d612024-05-16
43353-312-15EA - Each43353-312b2e5ab1f-1968-43f4-b86e-8c08ca535f4a12018-08-13
43353-312-28EA - Each43353-31295c6a410-3e5a-4e9d-82cd-6afdec25d57112024-04-05
43353-312-30EA - Each43353-3120022eab2-256b-4177-b736-ab041c7de61812017-11-06
43353-312-45EA - Each43353-3126bca5710-a9c0-4851-a714-d4732fdbb43b12018-10-11
43353-312-53EA - Each43353-3126ca70961-904f-411d-8d02-9f2a8866835c12017-11-06
43353-312-60EA - Each43353-3122a450ff3-1c9d-47ab-9921-a5449ec995e712017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-312TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 7 package rows20240124_b2422ca0-2f06-419f-aa0e-88c556b62399.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-acb0-444c5fbb70292026-08-05Boxed warning, Warnings, 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
ndc (product): 43353-312
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 CapsulePSNb2422ca0-2f06-419f-aa0e-88c556b623994
198242temazepam 30 MG Oral CapsulePSNb2422ca0-2f06-419f-aa0e-88c556b623994
198241temazepam 15 MG Oral CapsuleSCDb2422ca0-2f06-419f-aa0e-88c556b623994
198242temazepam 30 MG Oral CapsuleSCDb2422ca0-2f06-419f-aa0e-88c556b623994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-312-104335303121010 CAPSULE in 1 BOTTLE (43353-312-10) 10 capsule2018-06-27NoNoCurrent
43353-312-154335303121515 CAPSULE in 1 BOTTLE (43353-312-15) 15 capsule2017-09-210000-00-00NoNoCurrent
43353-312-284335303122828 CAPSULE in 1 BOTTLE (43353-312-28) 28 capsule2018-06-27NoNoCurrent
43353-312-304335303123030 CAPSULE in 1 BOTTLE (43353-312-30) 30 capsule2017-05-010000-00-00NoNoCurrent
43353-312-454335303124545 CAPSULE in 1 BOTTLE (43353-312-45) 45 capsule2017-09-210000-00-00NoNoCurrent
43353-312-534335303125360 CAPSULE in 1 BOTTLE (43353-312-53) 60 capsule2017-05-010000-00-00NoNoCurrent
43353-312-604335303126090 CAPSULE in 1 BOTTLE (43353-312-60) 90 capsule2017-05-010000-00-00NoNoCurrent