Dicyclomine Hydrochloride

Product NDC: 0904-6988
11-digit product format: 009046988
Labeler code: 0904
Product ID: 0904-6988_5d042b74-77b3-401e-b019-4807df743055
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA040230
Marketing category: ANDA
Marketing start: 1999-02-26
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dicyclomine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICYCLOMINE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CQ903KQA31	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991061	Internal RxNorm lookup
991086	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5eee0dff-d157-4534-adfb-c035b7042c07	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6988-61	Dicyclomine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		6
0904-6988-61	Dicyclomine Hydrochloride	100 in 1 CARTON	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6988-61	EA - Each	0904-6988	376ccdcd-59c5-49e6-b03e-cfc133e620ce	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6988	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 2 package rows	20250212_5eee0dff-d157-4534-adfb-c035b7042c07.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 ndc (product): 0904-6988
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
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	5eee0dff-d157-4534-adfb-c035b7042c07	6
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	5eee0dff-d157-4534-adfb-c035b7042c07	6
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	5eee0dff-d157-4534-adfb-c035b7042c07	6
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	5eee0dff-d157-4534-adfb-c035b7042c07	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6988-61	00904698861	100 BLISTER PACK in 1 CARTON (0904-6988-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	1999-02-26	0000-00-00	No	No	Current