Home NDC 0228-3004 Clonazepam
Product NDC 0228-3004
11-digit product format 002283004
Labeler code 0228
Product ID 0228-3004_9e152139-3fcf-4c44-b9b2-7110cde04d12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonazepam
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA074869
Marketing category ANDA
Marketing start 1997-02-12
Marketing end 2022-05-31
Substance CLONAZEPAM
Active strength 1 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074869-001 CLONAZEPAM CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 A074869-002 CLONAZEPAM CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 A074869-003 CLONAZEPAM CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31
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 · 126 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 2026-08-18 06:07:40 2026-07 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [STAT RX USA LLC] 4 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [STAT RX USA LLC] 4 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [STAT RX USA LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [STAT RX USA LLC] 4 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [STAT RX USA LLC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [STAT RX USA LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [STAT RX USA LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [ACTAVIS ELIZABETH LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [STAT RX USA LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [TYA PHARMACEUTICALS] 4 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB CLONAZEPAM TABLET [STAT RX USA LLC] 1 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [STAT RX USA LLC] 1 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLONAZEPAM TABLET [STAT RX USA LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [STAT RX USA LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [STAT RX USA LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1
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 0228-3004-11 00228300411 100 TABLET in 1 BOTTLE (0228-3004-11) 100 tablet 1997-02-12 2021-07-31 No No Current 0228-3004-50 00228300450 500 TABLET in 1 BOTTLE (0228-3004-50) 500 tablet 1997-02-12 2022-05-31 No No Current