Dicyclomine Hydrochloride

Product NDC: 68788-8578
Requested package NDC: 68788-8578-3
11-digit product format: 687888578
Labeler code: 68788
Product ID: 68788-8578_eab30315-f199-40ea-a2f2-a70d138c2c60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA040319
Marketing category: ANDA
Marketing start: 2024-02-01
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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
A040319-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		1999-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040319-001	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.

Product history page 1 of 2 · 43 observed 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
2026-09-14 22:38:34	2026-08	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040319-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040319-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040319-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040319-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040319-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040319-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040319-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040319-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040319-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040319-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040319-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040319-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040319-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040319-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040319-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040319-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040319-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040319-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040319-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040319-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040319-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040319-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040319-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040319-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040319-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040319-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040319-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040319-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040319-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040319-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040319-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040319-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040319-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040319-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040319-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040319-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040319-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040319-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040319-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040319-001	AB	1	`f41ea6bd6efb…`

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: Dicyclomine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICYCLOMINE HYDROCHLORIDE	10 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
991061	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
a5864c57-d73c-45c6-8985-7a041c84ccad	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
68788-8578-1	Dicyclomine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	3
68788-8578-3	Dicyclomine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	3
68788-8578-6	Dicyclomine Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	3
68788-8578-9	Dicyclomine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8578-3	EA - Each	68788-8578	6ca1782e-fad0-4c5a-a6bd-ec0a611788d2	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8578	DICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 4 package rows	20250322_a5864c57-d73c-45c6-8985-7a041c84ccad.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	e67ad329-6395-4fa0-a898-f13959034e26	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	508a7d45-4efd-8532-e063-6294a90a7741	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	21ec88b3-22c7-492b-bfb1-73d3f9852522	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a5864c57-d73c-45c6-8985-7a041c84ccad	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319 ndc (package): 68788-8578-3 ndc (product): 68788-8578 ndc11 (package): 68788857803
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	20ef2c05-d0a4-405c-e063-6394a90ae697	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	07361f0e-90c7-4531-8d3f-1ec5e7fed40d	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aurobindo Pharma Limited	ec746016-eed0-4e37-bb9c-cb430c8a7f07	2023-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319

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
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	a5864c57-d73c-45c6-8985-7a041c84ccad	3
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	a5864c57-d73c-45c6-8985-7a041c84ccad	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8578-3	68788857803	30 CAPSULE in 1 BOTTLE (68788-8578-3)	30 capsule	2024-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Preferred Pharmaceuticals Inc.	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	3