Application 040161

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

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
A040161-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1996-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040161-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040161-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040161-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040161-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040161-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040161-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040161-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040161-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040161-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040161-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040161-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040161-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040161-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040161-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040161-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040161-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040161-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040161-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040161-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040161-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040161-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040161-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040161-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040161-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040161-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040161-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040161-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040161-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040161-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040161-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040161-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040161-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040161-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040161-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040161-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040161-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040161-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040161-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040161-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040161-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040161-001	AB	1	`e64feba35796…`

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	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2c656550-7e5b-445f-e063-6294a90a8f52	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040161 application number: ANDA040161
Dicyclomine	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5a553bda-1e3d-4b80-913f-73dd54655033	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040161 application number: ANDA040161 ndc (product): 0143-1227

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1227	Dicyclomine	Dicyclomine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1227	Dicyclomine	Dicyclomine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1227	Dicyclomine	Dicyclomine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1227	Dicyclomine	Dicyclomine Hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current
0615-1516	Dicyclomine	Dicyclomine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-597	Dicyclomine	Dicyclomine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
50090-5454	Dicyclomine	Dicyclomine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5454	Dicyclomine	Dicyclomine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5454	Dicyclomine	Dicyclomine hydrochloride	A-S Medication Solutions	ANDA	Current
52959-221	Dicyclomine	Dicyclomine Hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
53808-0899	Dicyclomine	Dicyclomine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55700-933	Dicyclomine	Dicyclomine hydrochloride	Quality Care Products, LLC	ANDA	Current
67296-1741	Dicyclomine	Dicyclomine hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1741	Dicyclomine	Dicyclomine hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1741	Dicyclomine	Dicyclomine hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68788-9934	Dicyclomine	Dicyclomine Hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
70934-518	Dicyclomine	Dicyclomine hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current