Home NDC 63629-2373 Chlordiazepoxide Hydrochloride and Clidinium Bromide
Product NDC 63629-2373
11-digit product format 636292373
Labeler code 63629
Product ID 63629-2373_63c2bb31-d823-4b66-9967-cdc0ecfb556c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA211421
Marketing category ANDA
Marketing start 2020-07-09
Substance CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Active strength 5; 2.5 mg/1; mg/1
Pharmacologic classes Anticholinergic [EPC], Benzodiazepine [EPC], Benzodiazepines [CS], Cholinergic Antagonists [MoA], Decreased Parasympathetic Acetylcholine Activity [PE], Digestive/GI System Activity Alteration [PE], GI Motility Alteration [PE]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211421-001 AB
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 2026-08-18 06:07:40 2026-07 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211421-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-07-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Chlordiazepoxide Hydrochloride and Clidinium Bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 CLIDINIUM BROMIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MFM6K1XWDK Internal UNII lookup 91ZQW5JF1Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 889614 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 63629-2373-1 Chlordiazepoxide Hydrochloride and Clidinium Bromide 100 in 1 BOTTLE CAPSULE 100 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2373 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 1 package rows 20230215_c3223f35-1baf-46bf-9eb3-55455f672d85.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chlordiazepoxide Hydrochloride and Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Bryant Ranch Prepack d4ed59f7-7624-480f-b151-2d4e9b6b7013 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211421 application number: ANDA211421 Chlordiazepoxide Hydrochloride and Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Bryant Ranch Prepack 160c6524-314f-404a-ac04-0f3bfae2fde3 2023-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211421 application number: ANDA211421 Chlordiazepoxide Hydrochloride and Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Bryant Ranch Prepack 68d8dca6-697d-401e-acaf-01bfe4c4da17 2023-08-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211421 application number: ANDA211421 Chlordiazepoxide Hydrochloride and Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Bryant Ranch Prepack c3223f35-1baf-46bf-9eb3-55455f672d85 2023-02-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211421 application number: ANDA211421 ndc (product): 63629-2373 Chlordiazepoxide Hydrochloride and Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Sunrise Pharmaceutical, Inc. 3cce1912-e7c8-4f30-bd76-dfa4b9d65bac 2022-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211421 application number: ANDA211421
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 63629-2373-1 63629237301 100 CAPSULE in 1 BOTTLE (63629-2373-1) 100 capsule 2022-06-24 0000-00-00 No No Current