temazepam

Product NDC
63187-132
11-digit product format
631870132
Labeler code
63187
Product ID
63187-132_297f2ef3-a614-4992-b087-fe26108471f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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 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
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 · 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
904b8986-24da-48eb-bb0a-33d41b4eb005Available 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
63187-132-30temazepam30 in 1 BOTTLECAPSULE304
63187-132-60temazepam60 in 1 BOTTLECAPSULE604
63187-132-90temazepam90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-132-30EA - Each63187-1327534fe59-6397-41e5-b89d-42a61bea6d3612021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [PROFICIENT RX LP]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [PROFICIENT RX LP]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [PROFICIENT RX LP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [PROFICIENT RX LP]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [PROFICIENT RX LP]1
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [PROFICIENT RX LP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-132TEMAZEPAM CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20230613_904b8986-24da-48eb-bb0a-33d41b4eb005.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
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
ndc (product): 63187-132
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 CapsulePSN904b8986-24da-48eb-bb0a-33d41b4eb0054
198241temazepam 15 MG Oral CapsuleSCD904b8986-24da-48eb-bb0a-33d41b4eb0054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-132-306318701323030 CAPSULE in 1 BOTTLE (63187-132-30) 30 capsule2019-01-010000-00-00NoNoCurrent
63187-132-606318701326060 CAPSULE in 1 BOTTLE (63187-132-60) 60 capsule2023-06-08NoNoCurrent
63187-132-906318701329090 CAPSULE in 1 BOTTLE (63187-132-90) 90 capsule2023-06-08NoNoCurrent