Home NDC 55289-660 temazepam
Product NDC 55289-660
11-digit product format 552890660
Labeler code 55289
Product ID 55289-660_58b31552-c16f-5f7f-e063-6294a90ab7f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name temazepam
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, 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 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071457-001 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 A071457-002 TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 A071457-003 TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071457-002 TEMAZEPAM 7.5MG CAPSULE / ORAL AB 2012-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071457-003 TEMAZEPAM 22.5MG CAPSULE / ORAL AB 2012-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071457-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-04-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMAZEPAM 30 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198242 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 55289-660-01 temazepam 100 in 1 BOTTLE, PLASTIC CAPSULE 100 23 55289-660-30 temazepam 30 in 1 BOTTLE, PLASTIC CAPSULE 30 23 55289-660-60 temazepam 60 in 1 BOTTLE, PLASTIC CAPSULE 60 23 55289-660-82 temazepam 500 in 1 BOTTLE, PLASTIC CAPSULE 500 23 55289-660-90 temazepam 90 in 1 BOTTLE, PLASTIC CAPSULE 90 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded temazepam ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 temazepam ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 alcohol INACTIVE INGREDIENT 3K9958V90M TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 ammonia INACTIVE INGREDIENT 5138Q19F1X TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 gelatin INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 shellac INACTIVE INGREDIENT 46N107B71O TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 starch, corn INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-660 TEMAZEPAM CAPSULE [PD-RX PHARMACEUTICALS, INC.] 22 Current NDC, Legacy NDC, 5 package rows 20241012_62379cd5-a314-43eb-a1ee-33997623bfa3.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 2 of 2 · 23 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 55289-660-01 55289066001 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01) 100 capsule 2016-01-21 0000-00-00 No No Current 55289-660-30 55289066030 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30) 30 capsule 2016-01-21 0000-00-00 No No Current 55289-660-60 55289066060 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60) 60 capsule 2016-01-21 0000-00-00 No No Current 55289-660-82 55289066082 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82) 500 capsule 2020-04-20 0000-00-00 No No Current 55289-660-90 55289066090 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90) 90 capsule 2016-01-21 0000-00-00 No No Current