Dicyclomine Hydrochloride

Product NDC: 68071-3555
11-digit product format: 680713555
Labeler code: 68071
Product ID: 68071-3555_10abba06-dda8-24b2-e063-6394a90a7ae1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA040317
Marketing category: ANDA
Marketing start: 2023-04-25
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 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 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
A040317-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / 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
A040317-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`e64feba35796…`

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	A040317-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040317-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040317-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040317-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040317-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040317-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040317-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040317-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040317-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040317-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040317-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040317-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040317-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040317-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040317-001	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A040317-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040317-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040317-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040317-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040317-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040317-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040317-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040317-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040317-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040317-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040317-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040317-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040317-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040317-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040317-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040317-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040317-001	AB	1	`a50c72e98297…`

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	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
0d07a460-5cb1-cd4b-e063-6294a90a291d	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
68071-3555-3	Dicyclomine Hydrochloride	30 in 1 BOTTLE	TABLET	30		2
68071-3555-6	Dicyclomine Hydrochloride	60 in 1 BOTTLE	TABLET	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3555	DICYCLOMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 2 package rows	20240206_0d07a460-5cb1-cd4b-e063-6294a90a291d.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1b2d5256-b75d-11f8-e063-6394a90ae9ed	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5370e633-53a3-3764-e063-6394a90a3cad	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	5025a55d-ff55-c810-e063-6294a90adfb3	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	5734fac5-893d-4afd-95a1-e7ab4fd1df3a	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3252540c-980d-40ca-e063-6394a90ad1c9	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	62be6437-db8c-431b-8e5f-780487cf2d43	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b420733-b3b7-e504-e063-6394a90abba7	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	226a3a6e-9419-448a-827f-01199b792762	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0d07a460-5cb1-cd4b-e063-6294a90a291d	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317 ndc (product): 68071-3555
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aurobindo Pharma Limited	d81b93f8-bebc-455e-82b6-9a3de3f82e92	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317

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	0d07a460-5cb1-cd4b-e063-6294a90a291d	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	0d07a460-5cb1-cd4b-e063-6294a90a291d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3555-3	68071355503	30 TABLET in 1 BOTTLE (68071-3555-3)	30 tablet	2023-12-21	No	No	Current
68071-3555-6	68071355506	60 TABLET in 1 BOTTLE (68071-3555-6)	60 tablet	2023-12-21	No	No	Current