temazepam

Product NDC
76420-475
Requested package NDC
76420-475-90
11-digit product format
764200475
Labeler code
76420
Product ID
76420-475_40a62008-e0ba-4776-e063-6394a90a21a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA071457
Marketing category
ANDA
Marketing start
1987-04-21
Substance
TEMAZEPAM
Active strength
30 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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-2184e616aacf4f…
2026-09-14 22:38:342026-08A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-2284e616aacf4f…
2026-08-18 06:07:402026-07A071457-001TEMAZEPAM30MGCAPSULE / ORALAB1987-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A071457-002TEMAZEPAM7.5MGCAPSULE / ORALAB2012-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A071457-003TEMAZEPAM22.5MGCAPSULE / ORALAB2012-06-22caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A071457-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A071457-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A071457-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A071457-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071457-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071457-003AB1caaa826d4ba7…
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…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM30 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198241Internal RxNorm lookup
198242Internal RxNorm lookup
198243Internal RxNorm lookup
485489Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
254a0273-c0f3-4d2d-b18e-4ab51ba4bc50Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-475-01temazepam100 in 1 BOTTLECAPSULE1002
76420-475-05temazepam500 in 1 BOTTLECAPSULE5002
76420-475-30temazepam30 in 1 BOTTLECAPSULE302
76420-475-60temazepam60 in 1 BOTTLECAPSULE602
76420-475-90temazepam90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-475-01EA - Each76420-475d7cac78d-bbe8-447b-be74-049c7a04c1a512025-11-13
76420-475-05EA - Each76420-475bedfb99f-ddd4-4f93-8c53-b049ddcc107512025-11-13
76420-475-30EA - Each76420-475804ac908-d9ee-4039-aa2e-7403f9f823b712025-11-13
76420-475-60EA - Each76420-475bb9da627-f057-43f1-9114-d968569a2ddd12025-11-13
76420-475-90EA - Each76420-475fa50d775-c331-4037-a698-03ab38ae34ff12025-11-13

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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
temazepamTEMAZEPAMBryant Ranch Prepack5d83e474-0932-49ae-ad92-ca278cd5f1d52026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMBryant Ranch Prepack1c08d30d-7c27-a09a-5240-7050771d5cc72026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
TemazepamTEMAZEPAMMajor Pharmaceuticals2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMPD-Rx Pharmaceuticals, Inc.62379cd5-a314-43eb-a1ee-33997623bfa32026-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071457
application number: ANDA071457
temazepamTEMAZEPAMAscend Laboratories, LLC8f54731f-c5b7-492c-acb0-444c5fbb70292026-08-05Boxed warning, Warnings, 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
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
ndc (package): 76420-475-90
ndc (product): 76420-475
ndc11 (package): 76420047590
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
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 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
198241temazepam 15 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
485489temazepam 22.5 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198243temazepam 7.5 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198241temazepam 15 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
485489temazepam 22.5 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198243temazepam 7.5 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-475-907642004759090 CAPSULE in 1 BOTTLE (76420-475-90) 90 capsule2025-09-18NoNoCurrent