Home NDC 0004-0068-01 Klonopin
Product NDC 0004-0068
Requested package NDC 0004-0068-01
11-digit product format 000040068
Labeler code 0004
Product ID 0004-0068_78069474-118f-4b14-ba38-42dcb1e0d51b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonazepam
Dosage form TABLET
Route ORAL
Labeler Genentech, Inc.
Application NDA017533
Marketing category NDA
Marketing start 1975-06-02
Marketing end 2024-01-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017533-001 KLONOPIN CLONAZEPAM 0.5MG TABLET / ORAL AB RLD, Approved before 1982 N017533-002 KLONOPIN CLONAZEPAM 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 N017533-003 KLONOPIN CLONAZEPAM 2MG TABLET / ORAL AB RLD, Approved before 1982 N017533-005 KLONOPIN CLONAZEPAM 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09 N017533-006 KLONOPIN CLONAZEPAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09
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 6 · 210 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 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017533-005 KLONOPIN 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017533-006 KLONOPIN 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 2680178bc6a6…
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 KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 Clonazepam ACTIVE MOIETY 5PE9FDE8GB KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 lactose INACTIVE INGREDIENT J2B2A4N98G KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 starch, corn INACTIVE INGREDIENT O8232NY3SJ KLONOPIN (CLONAZEPAM) TABLET [GENENTECH, INC.] 9 CLONAZEPAM ACTIVE INGREDIENT 5PE9FDE8GB KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 CLONAZEPAM ACTIVE MOIETY 5PE9FDE8GB KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KLONOPIN (CLONAZEPAM) TABLET [STAT RX USA LLC] 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Klonopin CLONAZEPAM H2-Pharma, LLC cfa0d79a-843c-4b88-95a1-e9511d649ca1 2025-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017533 application number: NDA017533
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 0004-0068-01 00004006801 100 TABLET in 1 BOTTLE, PLASTIC (0004-0068-01) 100 tablet 2010-08-26 2024-01-31 No No Current