Home NDC 67877-731 Chlordiazepoxide Hydrochloride and Clidinium Bromide
Product NDC 67877-731
11-digit product format 678770731
Labeler code 67877
Product ID 67877-731_541259c3-7b51-4c46-a11c-f199d185ace0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form CAPSULE
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA214065
Marketing category ANDA
Marketing start 2021-04-27
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 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214065-001 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 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214065-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-04-26 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 67877-731-01 Chlordiazepoxide Hydrochloride and Clidinium Bromide 100 in 1 BOTTLE CAPSULE 100 10 67877-731-05 Chlordiazepoxide Hydrochloride and Clidinium Bromide 500 in 1 BOTTLE CAPSULE 500 10 67877-731-33 Chlordiazepoxide Hydrochloride and Clidinium Bromide 10 in 1 BLISTER PACK CAPSULE 10 10 67877-731-38 Chlordiazepoxide Hydrochloride and Clidinium Bromide 100 in 1 CARTON CAPSULE 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-731 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [ASCEND LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 4 package rows 20230722_19fdde81-e0f2-4269-bd57-252a759b7593.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 · 3 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 67877-731-01 67877073101 100 CAPSULE in 1 BOTTLE (67877-731-01) 100 capsule 2021-04-27 0000-00-00 No No Current 67877-731-05 67877073105 500 CAPSULE in 1 BOTTLE (67877-731-05) 500 capsule 2021-04-27 0000-00-00 No No Current 67877-731-33 67877073133 10 in 1 BLISTER PACK Historical 67877-731-38 67877073138 100 BLISTER PACK in 1 CARTON (67877-731-38) / 10 CAPSULE in 1 BLISTER PACK (67877-731-33) 100 blister pack 2021-04-27 0000-00-00 No No Current