Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 71610-809
Requested package NDC: 71610-809-80
11-digit product format: 716100809
Labeler code: 71610
Product ID: 71610-809_159ed936-248b-38c9-e063-6394a90a0f2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diphenoxylate hydrochloride and atropine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA213413
Marketing category: ANDA
Marketing start: 2020-03-15
Substance: ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength: .025; 2.5 mg/1; mg/1
Pharmacologic classes: Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL	AA		2020-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213413-001	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
2026-02-19 14:30 UTC	2026-02	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213413-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	2020-02-20	`a50c72e98297…`

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	A213413-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213413-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213413-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213413-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213413-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213413-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213413-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213413-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213413-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213413-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213413-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213413-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213413-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213413-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213413-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213413-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213413-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213413-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213413-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213413-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213413-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213413-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213413-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213413-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213413-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213413-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213413-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213413-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213413-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213413-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213413-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213413-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213413-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213413-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213413-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213413-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213413-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenoxylate Hydrochloride and Atropine Sulfate
Listing expiration: 2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190572	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
14bf7191-580f-76dc-e063-6294a90aed2a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-809-53	Diphenoxylate Hydrochloride and Atropine Sulfate	60 in 1 BOTTLE	TABLET	60	2
71610-809-60	Diphenoxylate Hydrochloride and Atropine Sulfate	90 in 1 BOTTLE	TABLET	90	2
71610-809-70	Diphenoxylate Hydrochloride and Atropine Sulfate	120 in 1 BOTTLE	TABLET	120	2
71610-809-80	Diphenoxylate Hydrochloride and Atropine Sulfate	180 in 1 BOTTLE	TABLET	180	2
71610-809-90	Diphenoxylate Hydrochloride and Atropine Sulfate	240 in 1 BOTTLE	TABLET	240	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-809-53	EA - Each	71610-809	e1e067a5-f03a-4182-a5cb-cab6a539687f	1	2024-05-16
71610-809-60	EA - Each	71610-809	a75e52e2-35b3-4bc7-8d00-1e3745b52ae4	1	2024-05-16
71610-809-70	EA - Each	71610-809	8d6b6647-7849-4f54-b9af-0baaedc045c2	1	2024-05-16
71610-809-80	EA - Each	71610-809	92b19d5e-d406-4653-a98d-0f949904a46d	1	2024-06-10
71610-809-90	EA - Each	71610-809	5fbbf39d-d8d3-4c8c-96e5-d445a2729c58	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-809	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	2	Current NDC, 5 package rows	20240410_14bf7191-580f-76dc-e063-6294a90aed2a.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 · 12 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	REMEDYREPACK INC.	3d0e2877-7a74-433f-8a31-e3e54aa9dc9f	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Redpharm Drug	5342df5c-12bb-565c-e063-6294a90a4ade	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Preferred Pharmaceuticals Inc.	46d5b27b-a710-4767-b308-4f673ddb354c	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	PD-Rx Pharmaceuticals, Inc.	700aad61-fa8c-4ded-87b8-da966093075a	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Redpharm Drug Inc.	f4c35a82-5927-5bc2-e053-2a95a90aea4d	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Direct Rx	d9a36478-4788-4107-e053-2a95a90ad6da	2025-01-21	Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	A-S Medication Solutions	1be4dd7d-766c-4b3c-8b86-4f219ab44726	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	b3f58de9-1cc8-4bc5-842f-010cc48d3582	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	14bf7191-580f-76dc-e063-6294a90aed2a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413 ndc (package): 71610-809-80 ndc (product): 71610-809 ndc11 (package): 71610080980
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Leading Pharma, LLC	1c188bc9-7c21-4717-94a0-cdfb581fb776	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	A-S Medication Solutions	24077113-11b2-4cde-afa7-1a1e364173c2	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Proficient Rx LP	593f2d01-5d24-450e-a6cf-204b7420f971	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213413 application number: ANDA213413

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190572	diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	14bf7191-580f-76dc-e063-6294a90aed2a	2
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	14bf7191-580f-76dc-e063-6294a90aed2a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-809-80	71610080980	180 TABLET in 1 BOTTLE (71610-809-80)	180 tablet	2024-04-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V	Aphena Pharma Solutions - Tennessee, LLC	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	2