Dicyclomine Hydrochloride

Product NDC: 70518-3220
Requested package NDC: 70518-3220-0
11-digit product format: 705183220
Labeler code: 70518
Product ID: 70518-3220_cbe6d19c-a68f-e9cf-e053-2a95a90a8d0d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212286
Marketing category: ANDA
Marketing start: 2021-09-13
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3220	70518-3220-0	D	Discontinued by firm		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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A212286-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA		2020-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212286-001	AA

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
2026-08-18 06:07:40	2026-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212286-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212286-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212286-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212286-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212286-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212286-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212286-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212286-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212286-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212286-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212286-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212286-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212286-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212286-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212286-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212286-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212286-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212286-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212286-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212286-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212286-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212286-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212286-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212286-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212286-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212286-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212286-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212286-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212286-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212286-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212286-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212286-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212286-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212286-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212286-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212286-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212286-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212286-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212286-001	CGT	2020-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212286-001	CGT	2020-11-18	`c0c555d07b60…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3220-0	2023-03-22	C162847	48780-1	f386c64a-361b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
70518-3220-0	2023-01-30	C162847	48780-1	f386c64a-361b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3220-0	ML - Milliliter	70518-3220	b32f4cb9-ec66-47d5-a9b5-fd49542e3aab	1	2024-05-16

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	aa5bd79d-7f18-4032-8862-0c5429b2ecaf	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212286 application number: ANDA212286

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
70518-3220-0	70518322000	473 mL in 1 BOTTLE (70518-3220-0)	473 ml	2021-09-13	0000-00-00	No	No	Current