DICYCLOMINE HYDROCHLORIDE

Product NDC: 72789-539
Requested package NDC: 72789-539-95
11-digit product format: 727890539
Labeler code: 72789
Product ID: 72789-539_58e0e7fd-169e-6128-e063-6294a90a3557
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICYCLOMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA216760
Marketing category: ANDA
Marketing start: 2025-06-10
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 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
A216760-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216760-001	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	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216760-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-11-28	`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	A216760-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216760-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216760-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216760-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216760-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216760-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216760-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216760-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216760-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216760-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216760-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216760-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216760-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216760-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216760-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216760-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216760-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216760-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216760-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216760-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216760-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216760-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216760-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216760-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216760-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216760-001	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: 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
9d249073-0171-4bb0-8cad-13cb3713159f	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
72789-539-01	DICYCLOMINE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	TABLET	100		2
72789-539-95	DICYCLOMINE HYDROCHLORIDE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-539-01	EA - Each	72789-539	bee772fe-4dd5-4118-8483-a2fb80e5d596	1	2026-05-22
72789-539-95	EA - Each	72789-539	6f2b95ea-78b3-4d61-bf5c-17b8b0fe77ea	1	2026-05-22

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 · 3 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.	9d249073-0171-4bb0-8cad-13cb3713159f	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216760 application number: ANDA216760 ndc (package): 72789-539-95 ndc (product): 72789-539 ndc11 (package): 72789053995
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	dda92fd9-d0e2-447b-aae6-012f089a4c2f	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216760 application number: ANDA216760
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Solaris Pharma Corporation	d46259e6-5eca-4356-bc18-815104c925cc	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216760 application number: ANDA216760

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	9d249073-0171-4bb0-8cad-13cb3713159f	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	9d249073-0171-4bb0-8cad-13cb3713159f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-539-95	72789053995	1000 TABLET in 1 BOTTLE, PLASTIC (72789-539-95)	1000 tablet	2026-04-03	No	No	Current