Home NDC 62135-696 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Product NDC 62135-696
11-digit product format 621350696
Labeler code 62135
Product ID 62135-696_459b81bd-0d79-ace2-e063-6294a90a3482
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA213530
Marketing category ANDA
Marketing start 2020-10-20
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 1 .
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 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213530-001 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 2026-02-19 14:30 UTC 2026-02 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213530-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2020-10-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A213530-001 CGT 2021-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213530-001 CGT 2021-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213530-001 CGT 2021-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213530-001 CGT 2021-04-24 8869cabd3fbd…
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 62135-696-12 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 120 in 1 BOTTLE CAPSULE 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-696 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [CHARTWELL RX, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241011_a0d735c2-e7a9-4843-a78d-203c9598682d.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 62135-696-12 62135069612 120 CAPSULE in 1 BOTTLE (62135-696-12) 120 capsule 2022-06-08 0000-00-00 No No Current