Home NDC 0228-2077 Temazepam
Product NDC 0228-2077
11-digit product format 002282077
Labeler code 0228
Product ID 0228-2077_3050ee1e-c494-48ce-be40-6424e9661d87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA071620
Marketing category ANDA
Marketing start 1990-09-30
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071620-001 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 A071620-002 TEMAZEPAM TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071620-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1987-08-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A071620-002 TEMAZEPAM 15MG CAPSULE / ORAL AB 1987-08-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198241 Internal RxNorm lookup 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 0228-2077-10 Temazepam 100 in 1 BOTTLE CAPSULE 100 25 0228-2077-50 Temazepam 500 in 1 BOTTLE CAPSULE 500 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC] 5 TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] 3 TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [DIRECT RX] 1 TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [DIRECT RX] 1 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [DIRECT RX] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [DIRECT RX] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMAZEPAM CAPSULE [DIRECT RX] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [DIRECT RX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [DIRECT RX] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2077 TEMAZEPAM CAPSULE [ACTAVIS PHARMA, INC.] 24 Current NDC, Legacy NDC, 2 package rows 20250213_a4370eb4-b00d-4247-af8d-980e59fbbec6.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Temazepam TEMAZEPAM REMEDYREPACK INC. 85919240-0bac-4ed9-97aa-f1aa29be7ffa 2026-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 Temazepam TEMAZEPAM Bryant Ranch Prepack 38afa73c-7c87-440d-bece-f268e8e4a44c 2025-03-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 Temazepam TEMAZEPAM Actavis Pharma, Inc. a4370eb4-b00d-4247-af8d-980e59fbbec6 2025-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620 ndc (product): 0228-2077 Temazepam TEMAZEPAM CIV NuCare Pharmaceuticals,Inc. 617d1957-c414-7f34-e053-2a91aa0a3fe0 2024-07-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071620 application number: ANDA071620
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 0228-2077-10 00228207710 100 CAPSULE in 1 BOTTLE (0228-2077-10) 100 capsule 1990-09-30 0000-00-00 No No Current 0228-2077-50 00228207750 500 CAPSULE in 1 BOTTLE (0228-2077-50) 500 capsule 1990-09-30 0000-00-00 No No Current