DICYCLOMINE HYDROCHLORIDE

Product NDC: 61919-077
11-digit product format: 619190077
Labeler code: 61919
Product ID: 61919-077_25c58c92-034c-0e8e-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICYCLOMINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA085082
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-077		U	Excluded because listing certification expired	2026-08-11
excluded package	package	61919-077	61919-077-30	U	Excluded because listing certification expired	2026-08-11
excluded package	package	61919-077	61919-077-60	U	Excluded because listing certification expired	2026-08-11

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-077-30	U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-077-60	U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-077-60	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-077-30	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A085082-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		1986-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085082-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085082-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1986-06-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085082-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085082-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085082-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085082-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085082-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085082-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085082-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085082-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085082-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085082-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085082-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085082-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085082-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085082-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085082-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085082-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085082-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085082-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085082-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085082-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085082-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085082-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085082-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085082-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085082-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085082-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085082-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085082-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085082-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085082-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085082-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085082-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085082-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085082-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085082-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085082-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085082-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085082-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085082-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085082-001	AB	1	`cb3db0bc1861…`

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
61919-077-30	DICYCLOMINE HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30		3
61919-077-60	DICYCLOMINE HYDROCHLORIDE	60 in 1 BOTTLE	CAPSULE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-077-30	EA - Each	61919-077	8a3165ee-d5bf-4839-bbeb-de48f9273b37	1	2016-11-08
61919-077-60	EA - Each	61919-077	284f12f0-7515-44cf-a1ec-83dfdd22ad94	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-077	DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	3	Legacy NDC, 2 package rows	20161013_2131a563-f739-4aee-a3ea-cfdc399799ab.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	d9bb7ff1-8dbc-d191-e053-2995a90a13db	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	QPharma, Inc.	f5dd6ecc-440d-6c47-e053-2a95a90a92d3	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	87cd2a04-54d6-4022-b365-646692a42f56	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8c29140b-e181-4807-870f-28e315c6d4c4	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b3d591ad-4eb7-4cdf-93b2-62cd479e921b	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Quality Care Products, LLC	1d257aa6-9963-4732-93b0-797b06c994ce	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	40e21575-320f-2ac6-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	51742add-363d-3f9d-e054-00144ff8d46c	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5937c7b-cdfc-46e6-a0fa-541b24f91d47	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	b3b8ee01-ec7c-4b17-a237-59ba45cdf3f9	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	346bbb6a-3499-4e90-af22-95f1cd0c0417	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085082 application number: ANDA085082

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	2131a563-f739-4aee-a3ea-cfdc399799ab	3
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	2131a563-f739-4aee-a3ea-cfdc399799ab	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-077-30	61919007730	30 in 1 BOTTLE	Historical
61919-077-60	61919007760	60 in 1 BOTTLE	Historical