Dicyclomine Hydrochloride

Product NDC: 70518-4432
11-digit product format: 705184432
Labeler code: 70518
Product ID: 70518-4432_3c2eea67-bae1-297c-e063-6394a90a13f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA217054
Marketing category: ANDA
Marketing start: 2025-08-12
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
A217054-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		2022-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217054-001	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	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217054-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2022-12-27	`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	A217054-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217054-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217054-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217054-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217054-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217054-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217054-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217054-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217054-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217054-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217054-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217054-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217054-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217054-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217054-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217054-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217054-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217054-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217054-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217054-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217054-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217054-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217054-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217054-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A217054-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217054-001	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	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
8652905b-b3f1-4eed-bde8-ce507186ae9a	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
70518-4432-0	Dicyclomine Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		1

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	Redpharm Drug	58e713f9-6412-0a1a-e063-6394a90a91b6	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	AvPAK	141d3818-7a87-aaa0-e063-6294a90a4866	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	66cf2cc1-6011-4879-8b25-8701b0677ac6	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	59422db6-b22d-447a-9393-46347406b338	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	4f6f4402-865b-44fb-9bfe-4e224d57e6dc	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	8652905b-b3f1-4eed-bde8-ce507186ae9a	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054 ndc (product): 70518-4432
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	4ae8d2fd-a7fb-4cc4-a2cb-720c5a2e2022	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217054 application number: ANDA217054

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	8652905b-b3f1-4eed-bde8-ce507186ae9a	1
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	8652905b-b3f1-4eed-bde8-ce507186ae9a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4432-0	70518443200	30 CAPSULE in 1 BLISTER PACK (70518-4432-0)	30 capsule	2025-08-12	No	No	Current