Home NDC 61269-605 Klonopin
Product NDC 61269-605
11-digit product format 612690605
Labeler code 61269
Product ID 61269-605_63cfdab9-fb3d-4c2b-bf88-8ba841dba839
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonazepam
Dosage form TABLET
Route ORAL
Labeler H2-Pharma, LLC
Application NDA017533
Marketing category NDA
Marketing start 1975-06-02
Substance CLONAZEPAM
Active strength .5 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 43 .
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1982 N017533-005 KLONOPIN CLONAZEPAM 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09 N017533-006 KLONOPIN CLONAZEPAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09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 · 215 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 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…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…
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 Klonopin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONAZEPAM .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5PE9FDE8GB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197527 Internal RxNorm lookup 197528 Internal RxNorm lookup 197529 Internal RxNorm lookup 206157 Internal RxNorm lookup 206159 Internal RxNorm lookup 206160 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 61269-605-10 Klonopin 100 in 1 BOTTLE, PLASTIC TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61269-605 KLONOPIN (CLONAZEPAM) TABLET [H2-PHARMA, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241205_cfa0d79a-843c-4b88-95a1-e9511d649ca1.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 61269-605-10 61269060510 100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10) 100 tablet 2010-08-26 0000-00-00 No No Current