DICYCLOMINE HYDROCHLORIDE

Product NDC: 73473-800
11-digit product format: 734730800
Labeler code: 73473
Product ID: 73473-800_8aedf1df-44c6-47d1-8a9d-8ce2b757ae12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICYCLOMINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Solaris Pharma Corporation
Application: ANDA216639
Marketing category: ANDA
Marketing start: 2025-06-10
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 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
A216639-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		2023-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216639-001	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	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216639-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2023-03-24	`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	A216639-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216639-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216639-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216639-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216639-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216639-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216639-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216639-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216639-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216639-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216639-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216639-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216639-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216639-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216639-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216639-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216639-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216639-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216639-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216639-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216639-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216639-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216639-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	400ac94f-2cf6-bd52-e063-6294a90a4f05	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216639 application number: ANDA216639
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	dd3a8428-f71f-4f39-91c9-328d2a30eeba	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216639 application number: ANDA216639
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	c60cb7fd-0ec7-4b6c-a535-34d79b2167b6	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216639 application number: ANDA216639
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Solaris Pharma Corporation	4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f2	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216639 application number: ANDA216639 ndc (product): 73473-800

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
4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f2	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
73473-800-01	DICYCLOMINE HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE	100		3
73473-800-10	DICYCLOMINE HYDROCHLORIDE	1000 in 1 BOTTLE	CAPSULE	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73473-800-01	EA - Each	73473-800	8d0e75f9-affb-4a26-8746-e08300a47f4b	1	2025-08-11
73473-800-10	EA - Each	73473-800	dbe19e18-c250-4371-a139-1c1466a6f6b0	1	2025-08-11

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	4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f2	3
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73473-800-01	73473080001	100 CAPSULE in 1 BOTTLE (73473-800-01)	100 capsule	2025-06-10	No	No	Current
73473-800-10	73473080010	1000 CAPSULE in 1 BOTTLE (73473-800-10)	1000 capsule	2025-06-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DICYCLOMINE HYDROCHLORIDE	Solaris Pharma Corporation \| CorePharma, LLC	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	3