Dicyclomine Hydrochloride

Product NDC: 43063-045
Requested package NDC: 43063-045-04
11-digit product format: 430630045
Labeler code: 43063
Product ID: 43063-045_2b247a51-9783-e240-e063-6294a90a8907
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA085223
Marketing category: ANDA
Marketing start: 1986-07-30
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 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
A085223-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085223-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1986-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1986-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1986-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1986-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085223-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RS	1986-07-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085223-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085223-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085223-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085223-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085223-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085223-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085223-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085223-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085223-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085223-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085223-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085223-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085223-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085223-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085223-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085223-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085223-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085223-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085223-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085223-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085223-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085223-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085223-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085223-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085223-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085223-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085223-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085223-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085223-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085223-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085223-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085223-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085223-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085223-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085223-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085223-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085223-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085223-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085223-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085223-001	AB	1	`cb3db0bc1861…`

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	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
da0e1f63-cb90-4c2a-908f-7d81e672be10	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
43063-045-04	Dicyclomine Hydrochloride	4 in 1 BOTTLE, PLASTIC	TABLET	4	32
43063-045-06	Dicyclomine Hydrochloride	6 in 1 BOTTLE, PLASTIC	TABLET	6	32
43063-045-20	Dicyclomine Hydrochloride	20 in 1 BOTTLE, PLASTIC	TABLET	20	32
43063-045-30	Dicyclomine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	32
43063-045-60	Dicyclomine Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-045-04	EA - Each	43063-045	2d0b23f1-99eb-4ac9-bae5-5f7145696c1f	1	2012-07-24
43063-045-06	EA - Each	43063-045	e83a71e1-23c3-43ae-bfe1-49f33a9a8a22	1	2012-07-24
43063-045-20	EA - Each	43063-045	66355826-4901-47d1-a227-dc37faa91bf6	1	2018-06-11
43063-045-30	EA - Each	43063-045	7f76292a-14a5-4ed4-afb1-7cb0fa81da90	1	2018-06-11
43063-045-60	EA - Each	43063-045	5097b35e-01e5-4caa-bdb9-68f22822984b	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-045	DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	32	Current NDC, Legacy NDC, 5 package rows	20250109_da0e1f63-cb90-4c2a-908f-7d81e672be10.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	c195b8ea-c1bf-453f-e053-2a95a90a2121	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085223 application number: ANDA085223
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	da0e1f63-cb90-4c2a-908f-7d81e672be10	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085223 application number: ANDA085223 ndc (package): 43063-045-04 ndc (product): 43063-045 ndc11 (package): 43063004504
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	517646d8-366e-5cf2-e054-00144ff88e88	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085223 application number: ANDA085223
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5937c7b-cdfc-46e6-a0fa-541b24f91d47	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085223 application number: ANDA085223
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085223 application number: ANDA085223

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	da0e1f63-cb90-4c2a-908f-7d81e672be10	32
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	da0e1f63-cb90-4c2a-908f-7d81e672be10	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-045-04	43063004504	4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04)	4 tablet	2008-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	32