Dicyclomine Hydrochloride

Product NDC: 50268-199
11-digit product format: 502680199
Labeler code: 50268
Product ID: 50268-199_47e343c9-2e61-c288-e063-6394a90a0b5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA217054
Marketing category: ANDA
Marketing start: 2024-03-20
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 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 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
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
2026-08-18 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
2026-08-18 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…`

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	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
141d3818-7a87-aaa0-e063-6294a90a4866	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
50268-199-11	Dicyclomine Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		3
50268-199-15	Dicyclomine Hydrochloride	50 in 1 BOX	CAPSULE	50		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-199-11	EA - Each	50268-199	8eb780a6-907e-4b33-8550-4cb994b2feda	1	2024-04-05
50268-199-15	EA - Each	50268-199	eb8f0d59-2033-4a36-8aef-f2016d7a8354	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-199	DICYCLOMINE HYDROCHLORIDE CAPSULE [AVPAK]	2	Current NDC, 2 package rows	20240615_141d3818-7a87-aaa0-e063-6294a90a4866.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	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 ndc (product): 50268-199
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
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	141d3818-7a87-aaa0-e063-6294a90a4866	3
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	141d3818-7a87-aaa0-e063-6294a90a4866	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-199-11	50268019911	1 in 1 BLISTER PACK					Historical
50268-199-15	50268019915	50 BLISTER PACK in 1 BOX (50268-199-15) / 1 CAPSULE in 1 BLISTER PACK (50268-199-11)	50 blister pack	2024-03-20	No	No	Current