Dicyclomine Hydrochloride

Product NDC: 60760-638
11-digit product format: 607600638
Labeler code: 60760
Product ID: 60760-638_de9a2d03-382d-ca89-e053-2a95a90acff6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: St Mary's Medical Park Pharmacy
Application: ANDA040230
Marketing category: ANDA
Marketing start: 2022-05-03
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60760-638		D	Discontinued by firm		2026-08-17
excluded package	package	60760-638	60760-638-30	D	Discontinued by firm		2026-08-17

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
A040230-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1999-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040230-001	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	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040230-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-02-26	`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	A040230-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040230-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040230-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040230-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040230-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040230-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040230-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040230-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040230-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040230-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040230-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040230-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040230-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040230-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040230-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040230-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040230-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040230-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040230-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040230-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040230-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040230-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040230-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040230-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040230-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040230-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040230-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040230-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040230-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040230-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040230-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040230-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040230-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040230-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040230-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040230-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040230-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040230-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040230-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040230-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-638-30	EA - Each	60760-638	d7d84937-4c7e-4a26-8e5c-10645bc8da41	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-638	DICYCLOMINE HYDROCHLORIDE TABLET [ST MARY'S MEDICAL PARK PHARMACY]	1	Legacy NDC	20220510_de9a2d03-382c-ca89-e053-2a95a90acff6.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Lannett Company, LLC	bd2cba10-70ec-4d1f-b46c-53d1de2ee130	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	3dc0f4f0-ee38-4f9b-abb6-6395215fe524	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	34db5a80-f445-41e5-b3c4-4c18abb09c92	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	7ff96d1f-fb87-4244-a697-1d93e10eb738	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Major Pharmaceuticals	5eee0dff-d157-4534-adfb-c035b7042c07	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	6fb9d156-f321-4f7d-b308-2a0e6056fd71	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	da82cb46-7b4b-1ef5-e053-2a95a90ad10d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Chartwell RX, LLC	d628ac1c-404d-45eb-8aab-0e550c95ed4a	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	82832a91-d16c-3a63-e053-2a91aa0a3ffb	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	American Health Packaging	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	b3c9dc85-2c6c-44f0-9c98-02673af934cb	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	da2c43f8-1c3a-447f-8994-f9899fb5e141	2018-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040230 application number: ANDA040230

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
60760-638-30	60760063830	30 TABLET in 1 BOTTLE, PLASTIC (60760-638-30)	30 tablet	2022-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	St Mary's Medical Park Pharmacy	2022-05-05	HUMAN PRESCRIPTION DRUG LABEL	1