Temazepam

Product NDC
43353-152
11-digit product format
433530152
Labeler code
43353
Product ID
43353-152_7e272f5a-86d5-48f5-92b5-50bc33f351b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071457
Marketing category
ANDA
Marketing start
2015-03-25
Substance
TEMAZEPAM
Active strength
7.5 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071457-001TEMAZEPAMTEMAZEPAM30MGCAPSULE / ORALAB1987-04-21
A071457-002TEMAZEPAMTEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22
A071457-003TEMAZEPAMTEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071457-001AB
A071457-002AB
A071457-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071457-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071457-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071457-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071457-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071457-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071457-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071457-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071457-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071457-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071457-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071457-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071457-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071457-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071457-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071457-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071457-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071457-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071457-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071457-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071457-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071457-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071457-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071457-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071457-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071457-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071457-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071457-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071457-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071457-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071457-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071457-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071457-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071457-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071457-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071457-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071457-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071457-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071457-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071457-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071457-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM7.5 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
198243Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4a241c7-a4de-4f6b-b831-e063cf8c3d54Available 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
43353-152-30Temazepam30 in 1 BOTTLECAPSULE302
43353-152-53Temazepam60 in 1 BOTTLECAPSULE602
43353-152-60Temazepam90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-152-30EA - Each43353-15213bf1678-7729-4e39-a208-cf2e067f194f12016-07-19
43353-152-53EA - Each43353-15224f0d43c-5fd5-46b4-be51-2b636de7f37912017-11-06
43353-152-60EA - Each43353-1523e71e71a-683c-41cb-b2cf-4204f0922f7712016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-152TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20171019_d4a241c7-a4de-4f6b-b831-e063cf8c3d54.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 2 · 24 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): 071457
application number: ANDA071457
temazepamTEMAZEPAMPreferred Pharmaceuticals Inc.7e3fd8fe-fb8a-4577-b540-0e3fefe636272026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack4fe8192a-0f65-4958-8b6d-e87b9fae9eb52025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepackbbb6e233-dc6b-43a7-8203-d91421d899212025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMA-S Medication Solutions19b2711e-587a-47d2-ab62-d564e7b871952025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMPD-Rx Pharmaceuticals, Inc.62379cd5-a314-43eb-a1ee-33997623bfa32025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepackdadc2f66-7fa5-4be4-a9d0-d96e5836f5502025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMAsclemed USA, Inc.254a0273-c0f3-4d2d-b18e-4ab51ba4bc502025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
TemazepamTEMAZEPAMMajor Pharmaceuticals2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d2025-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMAvPAK08183adb-af12-fcb2-e063-6394a90afea42025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepacked068e02-a9c6-41ce-beca-83762720663d2024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack8af67441-167f-4cc8-a498-c4377ba41c6d2024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack5d83e474-0932-49ae-ad92-ca278cd5f1d52024-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMNuCare Pharmaceuticals,Inc.62fc08cd-8143-1652-e053-2a91aa0ad7ed2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack6559dfee-c29b-4707-8b30-8ca14bf23ea02024-03-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a92024-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMAphena Pharma Solutions - Tennessee, LLCb2422ca0-2f06-419f-aa0e-88c556b623992024-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack1e37d59b-b8be-46ef-8706-fffd563a8c152024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack1c08d30d-7c27-a09a-5240-7050771d5cc72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack0e752dda-f00f-4123-b59f-aa911b897a5a2023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198243temazepam 7.5 MG Oral CapsulePSNd4a241c7-a4de-4f6b-b831-e063cf8c3d542
198243temazepam 7.5 MG Oral CapsuleSCDd4a241c7-a4de-4f6b-b831-e063cf8c3d542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-152-304335301523030 CAPSULE in 1 BOTTLE (43353-152-30) 30 capsule2016-02-220000-00-00NoNoCurrent
43353-152-534335301525360 CAPSULE in 1 BOTTLE (43353-152-53) 60 capsule2016-04-290000-00-00NoNoCurrent
43353-152-604335301526090 CAPSULE in 1 BOTTLE (43353-152-60) 90 capsule2016-02-160000-00-00NoNoCurrent