Dicyclomine Hydrochloride

Product NDC: 67296-2226
11-digit product format: 672962226
Labeler code: 67296
Product ID: 67296-2226_5197d491-0afe-2fb9-e063-6294a90a4bf9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA217916
Marketing category: ANDA
Marketing start: 2023-09-13
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-2226		E	Excluded after deficient or non-compliant submission was not corrected		2026-08-10
excluded package	package	67296-2226	67296-2226-5	E	Excluded after deficient or non-compliant submission was not corrected		2026-08-10

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
A217916-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2023-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A217916-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217916-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217916-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217916-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217916-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217916-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217916-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217916-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217916-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217916-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217916-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217916-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217916-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217916-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217916-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217916-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217916-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217916-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217916-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217916-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217916-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f755a917-03bc-45af-a1e3-50286868bfdb	Product name	9	20250303
f27796e1-d653-495b-932a-f51768e9be8a	Product name	2	20211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2226-5	Dicyclomine Hydrochloride	56 in 1 BOTTLE, PLASTIC	TABLET	56		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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	4dddbff3-2531-b35e-e063-6294a90a1d3b	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	2b33ef28-2b71-46c4-bb2f-694fefcd59ab	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3ee013cc-ab23-40a1-a44d-1d027c63b132	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	8561b68a-c88b-4047-9fcf-2df7344543b2	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bionpharma Inc.	051bfee3-06cf-309a-e063-6394a90a0bb3	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CQ903KQA31	DICYCLOMINE HYDROCHLORIDE	67-92-5	DICYCLOMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	5198641d-bba1-b053-e063-6394a90a592b	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	5198641d-bba1-b053-e063-6394a90a592b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2226-5	67296222605	56 TABLET in 1 BOTTLE, PLASTIC (67296-2226-5)	56 tablet	2023-09-13	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Bionpharma Inc. \| Redpharm Drug	2026-05-12	HUMAN PRESCRIPTION DRUG LABEL	1