Dicyclomine hydrochloride

Product NDC: 68071-5298
Requested package NDC: 68071-5298-3
11-digit product format: 680715298
Labeler code: 68071
Product ID: 68071-5298_53e88b6b-5245-b38e-e063-6394a90a1d10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA218952
Marketing category: ANDA
Marketing start: 2024-11-15
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 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
A218952-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2024-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218952-001	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.

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	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218952-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2024-11-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218952-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218952-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218952-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218952-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218952-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218952-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218952-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218952-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218952-001	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218952-001	AB	1	`a50c72e98297…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
53e8777d-d54f-a9da-e063-6294a90a1608	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	53e8777d-d54f-a9da-e063-6294a90a1608	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218952 application number: ANDA218952 ndc (package): 68071-5298-3 ndc (product): 68071-5298 ndc11 (package): 68071529803
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	0a97e9c8-7046-4b92-93ad-dd9e01ce0fc4	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218952 application number: ANDA218952

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
68071-5298-3	68071529803	30 TABLET in 1 BOTTLE (68071-5298-3)	30 tablet	2026-06-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine hydrochloride	NuCare Pharmaceuticals, Inc.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1