Home NDC 72888-134 clonazepam
Product NDC 72888-134
11-digit product format 728880134
Labeler code 72888
Product ID 72888-134_52c6d077-2562-84e0-e063-6394a90ae280
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonazepam
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA216988
Marketing category ANDA
Marketing start 2026-05-21
Substance CLONAZEPAM
Active strength .25 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216988-001 CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-002 CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-003 CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-004 CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-005 CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 A216988-001 CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216988-002 CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216988-003 CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216988-004 CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216988-005 CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216988-001 CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216988-002 CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216988-003 CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216988-004 CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216988-005 CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-001 CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-002 CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-003 CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-004 CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-005 CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 clonazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONAZEPAM .25 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349194 Internal RxNorm lookup 349195 Internal RxNorm lookup 349196 Internal RxNorm lookup 349197 Internal RxNorm lookup 349198 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 72888-134-29 clonazepam 10 in 1 CARTON TABLET, ORALLY DISINTEGRATING 10 1 72888-134-31 clonazepam 6 in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING 6 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72888-134-29 72888013429 10 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72888-134-29) 2026-05-21 No No Current 72888-134-31 72888013431 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72888-134-31) 2026-05-21 No No Current