Home NDC 60219-1677 chlordiazepoxide hydrochloride and clidinium bromide
Product NDC 60219-1677
11-digit product format 602191677
Labeler code 60219
Product ID 60219-1677_4c4923d9-915c-441a-90ee-fca641301d6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlordiazepoxide hydrochloride and clidinium bromide
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA215555
Marketing category ANDA
Marketing start 2021-10-25
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 43 .
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 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215555-001 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 2026-09-14 22:38:34 2026-08 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215555-001 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 5MG;2.5MG CAPSULE / ORAL AB 2021-10-25 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 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 60219-1677-1 chlordiazepoxide hydrochloride and clidinium bromide 100 in 1 BOTTLE, PLASTIC CAPSULE 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1677 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] 12 Current NDC, Legacy NDC, 1 package rows 20250107_b4ef805f-9fc3-47f7-b1f7-328c54970e5d.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 60219-1677-1 60219167701 100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1677-1) 100 capsule 2021-10-25 0000-00-00 No No Current