Dicyclomine Hydrochloride

Product NDC: 67296-1039
11-digit product format: 672961039
Labeler code: 67296
Product ID: 67296-1039_d60f91b5-252e-145d-e053-2995a90af686
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA040230
Marketing category: ANDA
Marketing start: 1999-02-26
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67296-1039		I	Inactivated by FDA	2026-08-17
excluded package	package	67296-1039	67296-1039-1	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-1039	67296-1039-7	I	Inactivated by FDA	2026-08-17
excluded package	package	67296-1039	67296-1039-9	I	Inactivated by FDA	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 · 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
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	67296-1039		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1039	67296-1039-1	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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 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
67296-1039-1	2026-01-29	C162847	48780-1	49896155-a111-586f-e063-e6dba90add90	Dicyclomine 20 mg Tablet
67296-1039-7	2026-01-29	C162847	48780-1	49896155-a111-586f-e063-e6dba90add90	Dicyclomine 20 mg Tablet
67296-1039-9	2026-01-29	C162847	48780-1	49896155-a111-586f-e063-e6dba90add90	Dicyclomine 20 mg Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-1039-1	Dicyclomine Hydrochloride	10 in 1 BOTTLE	TABLET	10	7
67296-1039-7	Dicyclomine Hydrochloride	15 in 1 BOTTLE	TABLET	15	7
67296-1039-9	Dicyclomine Hydrochloride	56 in 1 BOTTLE	TABLET	56	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1039	DICYCLOMINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]	7	Legacy NDC, 3 package rows	20240712_4e2d33d8-84ad-2abd-e054-00144ff88e88.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	4e2d33d8-84ad-2abd-e054-00144ff88e88	7
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	4e2d33d8-84ad-2abd-e054-00144ff88e88	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1039-1	67296103901	10 TABLET in 1 BOTTLE (67296-1039-1)	10 tablet	1999-02-26	0000-00-00	No	No	Current
67296-1039-7	67296103907	15 in 1 BOTTLE						Historical
67296-1039-9	67296103909	56 in 1 BOTTLE						Historical