Dicyclomine Hydrochloride

Product NDC: 24979-200
11-digit product format: 249790200
Labeler code: 24979
Product ID: 24979-200_d1cace55-0a40-4a47-a4d9-d57ed5035686
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA216782
Marketing category: ANDA
Marketing start: 2023-07-01
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

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
A216782-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2023-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216782-001	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	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216782-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-06-01	`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	A216782-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216782-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216782-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216782-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216782-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216782-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216782-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216782-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216782-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216782-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216782-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216782-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216782-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216782-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216782-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216782-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216782-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216782-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216782-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216782-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216782-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216782-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216782-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dicyclomine Hydrochloride
Listing expiration: 2027-12-31

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
ceba627b-5fe2-4ab3-b3bc-d90c3a170a93	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	SPL version
24979-200-01	Dicyclomine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	7
24979-200-02	Dicyclomine Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	7
24979-200-03	Dicyclomine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-200-01	EA - Each	24979-200	6b27532c-c19c-45fc-9da4-783358c25cc5	1	2023-08-08
24979-200-03	EA - Each	24979-200	e352d856-40b4-4e73-9ee4-c1a62611a267	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-200	DICYCLOMINE HYDROCHLORIDE TABLET [TWI PHARMACEUTICALS, INC.]	5	Current NDC, 3 package rows	20231202_ceba627b-5fe2-4ab3-b3bc-d90c3a170a93.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	57e5f041-9a6e-9d0c-e063-6294a90ab54c	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	2ad04535-1c34-6c5c-e063-6294a90a0c17	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	05552560-6986-f9e8-e063-6394a90a4af0	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	ceba627b-5fe2-4ab3-b3bc-d90c3a170a93	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782 ndc (product): 24979-200
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	2c36b79f-153c-446c-899b-6e28ccff1dc8	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	1aebc66d-0636-45ef-8110-7ff49d4dced5	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1cebadd3-2c45-9cff-e063-6394a90aaceb	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1e0260d0-aaad-aa9f-e063-6294a90a531a	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216782 application number: ANDA216782

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	2c36b79f-153c-446c-899b-6e28ccff1dc8	8
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	2c36b79f-153c-446c-899b-6e28ccff1dc8	8
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	ceba627b-5fe2-4ab3-b3bc-d90c3a170a93	7
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	ceba627b-5fe2-4ab3-b3bc-d90c3a170a93	7
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	05552560-6986-f9e8-e063-6394a90a4af0	4
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	05552560-6986-f9e8-e063-6394a90a4af0	4
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	1aebc66d-0636-45ef-8110-7ff49d4dced5	3
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	1aebc66d-0636-45ef-8110-7ff49d4dced5	3
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	1cebadd3-2c45-9cff-e063-6394a90aaceb	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	1cebadd3-2c45-9cff-e063-6394a90aaceb	2
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	1e0260d0-aaad-aa9f-e063-6294a90a531a	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	2ad04535-1c34-6c5c-e063-6294a90a0c17	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	1e0260d0-aaad-aa9f-e063-6294a90a531a	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	2ad04535-1c34-6c5c-e063-6294a90a0c17	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
24979-200-01	24979020001	100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01)	100 tablet	2023-07-01	No	No	Current
24979-200-02	24979020002	500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02)	500 tablet	2023-07-01	No	No	Current
24979-200-03	24979020003	1000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03)	1000 tablet	2023-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Redpharm Drug	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	St. Mary's Medical Park Pharmacy	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	2
Dicyclomine Hydrochloride	Golden State Medical Supply, Inc.	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	4
Dicyclomine Hydrochloride	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. \| Bora Pharmaceutical Laboratories Inc. Zhongli Plant \| BORA PHARMACEUTICAL LABORATORIES INC.	2026-02-23	HUMAN PRESCRIPTION DRUG LABEL	7
Dicyclomine Hydrochloride	REMEDYREPACK INC.	2026-02-12	HUMAN PRESCRIPTION DRUG LABEL	8
Dicyclomine Hydrochloride	A-S Medication Solutions	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	3
Dicyclomine Hydrochloride	Preferred Pharmaceuticals Inc.	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	3
Dicyclomine Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
Dicyclomine Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	1