Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 50090-3456
11-digit product format: 500903456
Labeler code: 50090
Product ID: 50090-3456_2df9b7b8-8617-4cb0-a344-98c330880d3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA086727
Marketing category: ANDA
Marketing start: 2017-07-07
Marketing end: 0000-00-00
Substance: DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active strength: 3 mg/1; mg/1
Pharmacologic classes: Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2021-12-31
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	50090-3456	50090-3456-0	D	Discontinued by firm		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3456-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3456-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3456-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3456-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3456-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3456-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3456-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3456-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3456-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3456-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3456-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3456-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3456-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3456-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3456-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3456-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3456-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3456-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3456-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3456-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3456-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3456-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3456-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3456-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3456-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3456-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3456-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3456-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3456-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3456-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3456-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3456-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3456-2	`367a005e9d99…`	`383a685ebd0f…`

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
A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086727-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086727-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086727-001	AA	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086727-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086727-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086727-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086727-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086727-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086727-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086727-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086727-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086727-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086727-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086727-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086727-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086727-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086727-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086727-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086727-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086727-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086727-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086727-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086727-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086727-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086727-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086727-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086727-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086727-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086727-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086727-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenoxylate Hydrochloride and Atropine Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENOXYLATE HYDROCHLORIDE	.025 mg/1
ATROPINE SULFATE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W24OD7YW48	Internal UNII lookup
03J5ZE7KA5	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f94a0189-40d2-42e0-8d2b-c9dc433faad1	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3456-0	2023-02-07	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
50090-3456-1	2023-02-07	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
50090-3456-2	2023-02-07	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
50090-3456-0	2023-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
50090-3456-1	2023-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
50090-3456-2	2023-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3456-0	EA - Each	50090-3456	f79a2ad8-403e-45c4-9a6b-28b7c05bbaa1	1	2018-11-06
50090-3456-1	EA - Each	50090-3456	97a17122-0f6b-42bf-9f84-eb43c7af6b7c	1	2021-09-07
50090-3456-2	EA - Each	50090-3456	28a017a7-d7d0-47d0-9093-e480bbbaeb4c	1	2018-11-06

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	A-S Medication Solutions	f94a0189-40d2-42e0-8d2b-c9dc433faad1	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727 ndc (product): 50090-3456
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	bd08ed90-dd26-4629-83c0-0f75af6ebb95	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	64be1529-f290-422c-a076-32c0e1ced1a1	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ANI Pharmaceuticals, Inc.	73dc5f91-d562-44c5-a556-66c96ed1dd82	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	NuCare Pharmaceuticals,Inc.	575c38b4-7ec0-6d25-e053-2a91aa0a80fc	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Proficient Rx LP	c832ef16-a06e-4e47-9df3-ab33bdfa6e56	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	435e5e75-5a4c-4806-8d9e-d4be3fef9229	2017-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W24OD7YW48	DIPHENOXYLATE HYDROCHLORIDE	3810-80-8	DIPHENOXYLATE HYDROCHLORIDE
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3456-0	50090345600	15 TABLET in 1 BOTTLE (50090-3456-0)	15 tablet	2018-05-17	0000-00-00	No	No	Current
50090-3456-1	50090345601	20 TABLET in 1 BOTTLE, PLASTIC (50090-3456-1)	20 tablet	2017-07-07	0000-00-00	No	No	Current
50090-3456-2	50090345602	30 TABLET in 1 BOTTLE (50090-3456-2)	30 tablet	2018-05-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only	A-S Medication Solutions	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	13