Dicyclomine Hydrochloride

Product NDC: 71205-043
Requested package NDC: 71205-043-60
11-digit product format: 712050043
Labeler code: 71205
Product ID: 71205-043_1edd7ce3-5349-48f6-9574-0af4b3437f7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dicyclomine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040319
Marketing category: ANDA
Marketing start: 1999-11-03
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: 2020-12-31
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	71205-043	71205-043-60	D	Discontinued by firm		2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-043	71205-043-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-043	71205-043-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A040319-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		1999-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040319-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040319-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1999-09-07	`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	A040319-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040319-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040319-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040319-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040319-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040319-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040319-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040319-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040319-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040319-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040319-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040319-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040319-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040319-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040319-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040319-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040319-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040319-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040319-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040319-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040319-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040319-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040319-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040319-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040319-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040319-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040319-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040319-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040319-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040319-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040319-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040319-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040319-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040319-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040319-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040319-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040319-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040319-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040319-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040319-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-043-30	EA - Each	71205-043	f0057d2a-5780-4c77-aeb0-f340d195e3aa	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-043	DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	3	Legacy NDC	20191030_058b8aa0-0c23-430a-a8fd-0191106fd9e8.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	508a7d45-4efd-8532-e063-6294a90a7741	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	21ec88b3-22c7-492b-bfb1-73d3f9852522	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	e67ad329-6395-4fa0-a898-f13959034e26	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a5864c57-d73c-45c6-8985-7a041c84ccad	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	20ef2c05-d0a4-405c-e063-6394a90ae697	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	07361f0e-90c7-4531-8d3f-1ec5e7fed40d	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aurobindo Pharma Limited	ec746016-eed0-4e37-bb9c-cb430c8a7f07	2023-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040319 application number: ANDA040319

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
71205-043-60	71205004360	60 CAPSULE in 1 BOTTLE, PLASTIC (71205-043-60)	60 capsule	2018-06-01	0000-00-00	No	No	Current