Home NDC 43547-612 Temazepam
Product NDC 43547-612
11-digit product format 435470612
Labeler code 43547
Product ID 43547-612_5f04458d-b81c-47f8-ab06-3c47dffc5e4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name temazepam
Dosage form CAPSULE
Route ORAL
Labeler Solco Healthcare U.S., LLC
Application ANDA201781
Marketing category ANDA
Marketing start 2023-01-05
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201781-001 TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 A201781-002 TEMAZEPAM TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 A201781-003 TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 A201781-004 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201781-001 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2015-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201781-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 2015-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201781-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2015-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201781-004 TEMAZEPAM 30MG CAPSULE / ORAL AB 2015-06-04 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Temazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMAZEPAM 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CHB1QD2QSS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198241 Internal RxNorm lookup 198242 Internal RxNorm lookup 198243 Internal RxNorm lookup 485489 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43547-612-10 Temazepam 100 in 1 BOTTLE, PLASTIC CAPSULE 100 6 43547-612-50 Temazepam 500 in 1 BOTTLE, PLASTIC CAPSULE 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-612 TEMAZEPAM CAPSULE [SOLCO HEALTHCARE U.S., LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240929_3ce42f0e-821e-4c9a-8f6b-60621628fd4b.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43547-612-10 43547061210 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-10) 100 capsule 2023-01-05 0000-00-00 No No Current 43547-612-50 43547061250 500 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-50) 500 capsule 2023-01-05 0000-00-00 No No Current