temazepam

Product NDC
55289-196
11-digit product format
552890196
Labeler code
55289
Product ID
55289-196_4199da42-51af-009d-e063-6394a90a906c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
45ef5e9c-f381-48d3-895d-e1d29be856acAvailable 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
55289-196-01temazepam100 in 1 BOTTLE, PLASTICCAPSULE10026
55289-196-14temazepam14 in 1 BOTTLE, PLASTICCAPSULE1426
55289-196-30temazepam30 in 1 BOTTLE, PLASTICCAPSULE3026
55289-196-60temazepam60 in 1 BOTTLE, PLASTICCAPSULE6026
55289-196-82temazepam500 in 1 BOTTLE, PLASTICCAPSULE50026
55289-196-90temazepam90 in 1 BOTTLE, PLASTICCAPSULE9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-196-01EA - Each55289-196c38f80e2-8a4b-4999-8853-6ff2d6990cd912017-09-11
55289-196-14EA - Each55289-1962eafa6e1-7432-4b33-8b4c-a9e6ea2266e312012-07-24
55289-196-30EA - Each55289-19629852a33-b25c-438b-828a-7dad3a35622612012-07-24
55289-196-60EA - Each55289-19671095f0f-5215-4783-8e5c-24fdf170545a12016-03-04
55289-196-82EA - Each55289-196ea4a1357-2c81-433a-8c6b-de398643b23f12020-08-06
55289-196-90EA - Each55289-19650b4df6e-cbd8-4bf9-a708-b1604b3c982812016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-196TEMAZEPAM CAPSULE [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 6 package rows20241115_45ef5e9c-f381-48d3-895d-e1d29be856ac.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
ndc (product): 55289-196
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 CapsulePSN45ef5e9c-f381-48d3-895d-e1d29be856ac26
198241temazepam 15 MG Oral CapsuleSCD45ef5e9c-f381-48d3-895d-e1d29be856ac26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-196-0155289019601100 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-01) 100 capsule2016-02-050000-00-00NoNoCurrent
55289-196-145528901961414 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-14) 14 capsule2016-02-050000-00-00NoNoCurrent
55289-196-305528901963030 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-30) 30 capsule2016-02-050000-00-00NoNoCurrent
55289-196-605528901966060 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-60) 60 capsule2016-02-050000-00-00NoNoCurrent
55289-196-8255289019682500 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-82) 500 capsule2020-04-200000-00-00NoNoCurrent
55289-196-905528901969090 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-90) 90 capsule2018-12-130000-00-00NoNoCurrent