Dicyclomine hydrochloride

Product NDC: 63629-3341
Requested package NDC: 63629-3341-7
11-digit product format: 636293341
Labeler code: 63629
Product ID: 63629-3341_c8a3893f-612c-4a03-b3de-6caaff80d52b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040204
Marketing category: ANDA
Marketing start: 1997-02-28
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-3341	63629-3341-7	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040204-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		1997-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040204-001	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 · 42 observed 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	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040204-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040204-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040204-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040204-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040204-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040204-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040204-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040204-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040204-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040204-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040204-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040204-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040204-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040204-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040204-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040204-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040204-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040204-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040204-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040204-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040204-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040204-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040204-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040204-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040204-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040204-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040204-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040204-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040204-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040204-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040204-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040204-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040204-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040204-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040204-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040204-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040204-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040204-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040204-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040204-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3341-1	2022-02-25	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-2	2022-02-25	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-3	2022-02-25	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-4	2022-02-25	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-5	2022-02-25	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-6	2022-02-25	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-1	2019-11-27	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-2	2019-11-27	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-3	2019-11-27	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-4	2019-11-27	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-5	2019-11-27	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
63629-3341-6	2019-11-27	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3341-1	EA - Each	63629-3341	662d6117-59e5-4639-ba65-032992083c80	1	2013-04-01
63629-3341-2	EA - Each	63629-3341	baa17352-15fc-412c-ab91-2a193215c039	1	2013-04-01
63629-3341-3	EA - Each	63629-3341	852ccf96-9221-422a-865d-59b6d0275a40	1	2013-04-01
63629-3341-4	EA - Each	63629-3341	fbd6ca4c-02a5-4480-8dee-d8512395d89f	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3

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	NCS HealthCare of KY, LLC dba Vangard Labs	a16e7b6b-dbc9-463d-9bde-dba4f25589cf	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040204 application number: ANDA040204
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	01413a77-48f8-1a8a-e063-6394a90ae494	2023-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040204 application number: ANDA040204
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	99d7d1ce-47b5-4bbd-afe0-908505a9a51b	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040204 application number: ANDA040204

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CQ903KQA31	DICYCLOMINE HYDROCHLORIDE	67-92-5	DICYCLOMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3341-7	63629334107	180 CAPSULE in 1 BOTTLE (63629-3341-7)	180 capsule	2015-05-29	0000-00-00	No	No	Current