Dicyclomine Hydrochloride

Product NDC: 71335-2506
Requested package NDC: 71335-2506-5
11-digit product format: 713352506
Labeler code: 71335
Product ID: 71335-2506_2c521bdf-ff4d-47e3-8776-0ba6e5e6613b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
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: 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
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
2026-09-14 22:38:34	2026-08	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	A217916-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217916-001	AB	1	`caaa826d4ba7…`
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…`

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	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
8561b68a-c88b-4047-9fcf-2df7344543b2	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
71335-2506-0	Dicyclomine Hydrochloride	10 in 1 BOTTLE	TABLET	10	2
71335-2506-1	Dicyclomine Hydrochloride	30 in 1 BOTTLE	TABLET	30	2
71335-2506-2	Dicyclomine Hydrochloride	40 in 1 BOTTLE	TABLET	40	2
71335-2506-3	Dicyclomine Hydrochloride	60 in 1 BOTTLE	TABLET	60	2
71335-2506-4	Dicyclomine Hydrochloride	90 in 1 BOTTLE	TABLET	90	2
71335-2506-5	Dicyclomine Hydrochloride	20 in 1 BOTTLE	TABLET	20	2
71335-2506-6	Dicyclomine Hydrochloride	21 in 1 BOTTLE	TABLET	21	2
71335-2506-7	Dicyclomine Hydrochloride	120 in 1 BOTTLE	TABLET	120	2
71335-2506-8	Dicyclomine Hydrochloride	100 in 1 BOTTLE	TABLET	100	2
71335-2506-9	Dicyclomine Hydrochloride	28 in 1 BOTTLE	TABLET	28	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2506-1	EA - Each	71335-2506	4b64062d-4101-44a5-9667-d5df765fcaf2	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2506	DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2	Current NDC, 10 package rows	20250212_8561b68a-c88b-4047-9fcf-2df7344543b2.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 · 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 ndc (package): 71335-2506-5 ndc (product): 71335-2506 ndc11 (package): 71335250605
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	8561b68a-c88b-4047-9fcf-2df7344543b2	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	8561b68a-c88b-4047-9fcf-2df7344543b2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2506-5	71335250605	20 TABLET in 1 BOTTLE (71335-2506-5)	20 tablet	2024-10-07	No	No	Current