DICYCLOMINE HYDROCHLORIDE

Product NDC: 61919-324
11-digit product format: 619190324
Labeler code: 61919
Product ID: 61919-324_f2126a96-6338-7052-e053-2a95a90af277
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICYCLOMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA085223
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-324		I	Inactivated by FDA		2026-08-11
excluded package	package	61919-324	61919-324-30	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-324-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-324-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-324-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-324-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-324-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-324-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-324-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-324-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-324-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-324-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-324-30	2025-01-30	C162847	48780-1	2cef2736-83e9-d83d-e063-dadaa90ab31f	DICYCLOMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-324-30	DICYCLOMINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-324-30	EA - Each	61919-324	c17a6664-594f-4403-8920-fa741d4f2ce2	1	2015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-324	DICYCLOMINE HYDROCHLORIDE TABLET [DIRECT RX]	5	Legacy NDC, 1 package rows	20230420_ebaf5799-80f9-4e16-9e11-99eaf30531f4.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
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	ebaf5799-80f9-4e16-9e11-99eaf30531f4	5
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	ebaf5799-80f9-4e16-9e11-99eaf30531f4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-324-30	61919032430	30 TABLET in 1 BOTTLE (61919-324-30)	30 tablet	2015-01-01	0000-00-00	No	No	Current