Application 040169

Type: ANDA
Sponsor: GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML	No	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
A040169-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040169-001	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.

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`e64feba35796…`

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	A040169-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040169-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040169-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040169-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040169-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040169-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040169-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040169-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040169-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040169-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040169-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040169-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040169-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040169-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040169-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040169-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040169-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040169-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040169-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040169-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040169-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040169-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040169-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040169-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040169-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040169-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040169-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040169-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040169-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040169-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040169-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040169-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040169-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040169-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040169-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040169-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040169-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040169-001	AA	1	`a50c72e98297…`

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	Par Health USA, LLC	bb099db9-f635-4a64-8892-6236971dec45	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040169 application number: ANDA040169 ndc (product): 0603-1161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-1161	dicyclomine hydrochloride	dicyclomine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-1161	dicyclomine hydrochloride	dicyclomine hydrochloride	Par Pharmaceutical	ANDA	Current
17856-1161	dicyclomine hydrochloride	dicyclomine hydrochloride	Atlantic Biologicals Corps	ANDA	Current
46672-657	dicyclomine hydrochloride	dicyclomine hydrochloride	Mikart, Inc.	ANDA	Current
53703-800	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	Entera Health, Inc.	ANDA	Current
63629-2179	dicyclomine hydrochloride	dicyclomine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2179	dicyclomine hydrochloride	dicyclomine hydrochloride	Bryant Ranch Prepack	ANDA	Current
68151-1161	dicyclomine hydrochloride	dicyclomine hydrochloride	Carilion Materials Management	ANDA	Current