Dicyclomine Hydrochloride

Product NDC: 70518-3917
Requested package NDC: 70518-3917-2
11-digit product format: 705183917
Labeler code: 70518
Product ID: 70518-3917_4aa0eee6-1269-e6ee-e063-6294a90a4db1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA216782
Marketing category: ANDA
Marketing start: 2023-11-19
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 1.

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
2026-02-19 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
2026-02-19 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
2c36b79f-153c-446c-899b-6e28ccff1dc8	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
70518-3917-0	Dicyclomine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	8
70518-3917-1	Dicyclomine Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	8
70518-3917-2	Dicyclomine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	8
70518-3917-3	Dicyclomine Hydrochloride	20 in 1 BOTTLE, PLASTIC	TABLET	20	8
70518-3917-4	Dicyclomine Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3917	DICYCLOMINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	4	Current NDC, 5 package rows	20240720_2c36b79f-153c-446c-899b-6e28ccff1dc8.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	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
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 ndc (package): 70518-3917-2 ndc (product): 70518-3917 ndc11 (package): 70518391702
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3917-2	70518391702	30 TABLET in 1 BLISTER PACK (70518-3917-2)	30 tablet	2024-07-19	No	No	Current