Dicyclomine hydrochloride

Product NDC: 0832-6052
Requested package NDC: 0832-6052-10
11-digit product format: 008326052
Labeler code: 0832
Product ID: 0832-6052_43687d93-357b-a540-e063-6394a90a2748
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA216760
Marketing category: ANDA
Marketing start: 2022-11-28
Marketing end: 2026-09-30
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0832-6052	0832-6052-10	D	Discontinued by firm		2026-08-17

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
A216760-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216760-001	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
2026-08-18 06:07:40	2026-07	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216760-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216760-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216760-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216760-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216760-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216760-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216760-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216760-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216760-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216760-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216760-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216760-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216760-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216760-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216760-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216760-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216760-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216760-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216760-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216760-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216760-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216760-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216760-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216760-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216760-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dicyclomine hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICYCLOMINE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CQ903KQA31	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991086	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dda92fd9-d0e2-447b-aae6-012f089a4c2f	Available on FDA.report

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
0832-6052-10	Dicyclomine hydrochloride	1000 in 1 BOTTLE	TABLET	1000		3
0832-6052-11	Dicyclomine hydrochloride	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-6052-10	EA - Each	0832-6052	64316205-c415-4c86-bd25-8885168aaf60	1	2023-02-06
0832-6052-11	EA - Each	0832-6052	bb3a12af-4c99-44d0-9f35-c196868e9534	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-6052	DICYCLOMINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]	2	Current NDC, 2 package rows	20240713_dda92fd9-d0e2-447b-aae6-012f089a4c2f.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d249073-0171-4bb0-8cad-13cb3713159f	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216760 application number: ANDA216760
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	dda92fd9-d0e2-447b-aae6-012f089a4c2f	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216760 application number: ANDA216760 ndc (package): 0832-6052-10 ndc (product): 0832-6052 ndc11 (package): 00832605210
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Solaris Pharma Corporation	d46259e6-5eca-4356-bc18-815104c925cc	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216760 application number: ANDA216760

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	dda92fd9-d0e2-447b-aae6-012f089a4c2f	3
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	dda92fd9-d0e2-447b-aae6-012f089a4c2f	3
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	f6d02efd-ad65-99e9-e053-6394a90aa5d2	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	f6d02efd-ad65-99e9-e053-6394a90aa5d2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-6052-10	00832605210	1000 TABLET in 1 BOTTLE (0832-6052-10)	1000 tablet	2023-02-09	2026-06-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine hydrochloride	Upsher-Smith Laboratories, LLC	2025-11-12	HUMAN PRESCRIPTION DRUG LABEL	3
Dicyclomine hydrochloride	RedPharm Drug, Inc	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	2