Loperamide Hydrochloride

Product NDC: 71610-973
Requested package NDC: 71610-973-53
11-digit product format: 716100973
Labeler code: 71610
Product ID: 71610-973_45a1e9d4-58d3-98ef-e063-6394a90aac13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA073192
Marketing category: ANDA
Marketing start: 1993-05-01
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
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 43.

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
A073192-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		1992-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073192-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A073192-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073192-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073192-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Loperamide Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
77TI35393C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978006	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
45a1e6b0-1e2b-958a-e063-6394a90a261d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-973-53	Loperamide Hydrochloride	60 in 1 BOTTLE	CAPSULE	60		1
71610-973-60	Loperamide Hydrochloride	90 in 1 BOTTLE	CAPSULE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-973-53	EA - Each	71610-973	064a87a6-4577-4c0f-8038-117dbdd9fdc7	1	2026-03-17
71610-973-60	EA - Each	71610-973	c12b578c-24d5-4213-9ef6-83453fa979c2	1	2026-03-17

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	ca8de42f-8aea-4e35-ab3a-75ecea718f4f	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	45a1e6b0-1e2b-958a-e063-6394a90a261d	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192 ndc (package): 71610-973-53 ndc (product): 71610-973 ndc11 (package): 71610097353
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	American Health Packaging	42989f90-8ff5-44d1-a462-28c18ce02738	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3310a3c2-389a-4b27-a478-67c905789854	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	580e6cd4-3f05-4996-9dc3-c50d757ae210	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	A-S Medication Solutions	97c37571-9116-40d6-ba07-f4a5a8d9b689	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	865cf4c7-f643-451b-b0d4-d30bda621f7d	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3e898141-8d40-49f1-e054-00144ff88e88	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	af0b886f-c065-26dc-e053-2995a90ac471	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	8bf47ac3-746f-47c3-82b2-32ac979ff963	2016-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978006	loperamide HCl 2 MG Oral Capsule	PSN	45a1e6b0-1e2b-958a-e063-6394a90a261d	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	45a1e6b0-1e2b-958a-e063-6394a90a261d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-973-53	71610097353	60 CAPSULE in 1 BOTTLE (71610-973-53)	60 capsule	2025-12-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride Capsules USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	1