dicyclomine hydrochloride

Product NDC: 0054-0883
11-digit product format: 000540883
Labeler code: 0054
Product ID: 0054-0883_e135daff-043e-4944-baf8-dfea510cec60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dicyclomine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA040204
Marketing category: ANDA
Marketing start: 2026-09-15
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040204-001	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	10 mg/1

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	Sample	Exclude flag	Status
0054-0883-25	00054088325	100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0883-25)	100 capsule	2026-09-15	No	No	Current
0054-0883-31	00054088331	1000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0883-31)	1000 capsule	2026-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
dicyclomine hydrochloride	Hikma Pharmaceuticals USA Inc. \| Hikma Pharmaceuticals LLC \| Olon S.p.A.	2026-09-15	HUMAN PRESCRIPTION DRUG LABEL	2