Loperamide HCl

Product NDC: 72189-686
11-digit product format: 721890686
Labeler code: 72189
Product ID: 72189-686_59e1c4cf-17cd-13c9-e063-6294a90af61c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loperamide HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA218122
Marketing category: ANDA
Marketing start: 2026-08-25
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A218122-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2023-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218122-001	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.

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	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218122-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218122-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218122-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218122-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218122-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218122-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218122-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218122-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218122-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218122-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218122-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218122-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218122-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218122-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218122-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218122-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218122-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218122-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218122-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218122-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A218122-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A218122-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218122-001	AB	1	`a50c72e98297…`

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 HCl
Listing expiration: 2027-12-31

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
59e1c4cf-17cc-13c9-e063-6294a90af61c	Available on FDA.report

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 HCl	LOPERAMIDE HCL	Direct_Rx	59e1c4cf-17cc-13c9-e063-6294a90af61c	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122 ndc (product): 72189-686
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	REMEDYREPACK INC.	3fdfc0e5-56a2-48a0-8ee6-390a194a29f3	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Coupler LLC	518bb0f0-88f2-1c95-e063-6294a90a722f	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Redpharm Drug	3b0ac1a9-ffa6-9af6-e063-6294a90a2678	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Major Pharmaceuticals	1be585e2-ef49-4210-8a2d-22a326e4cc1b	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	86d94804-ad01-4106-8f23-033f3a6bab9e	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	A-S Medication Solutions	d572ecf7-ddc3-46fb-80a6-80b7b1b90a1b	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	NorthStar Rx LLC	858c2b62-98e6-46d7-9253-9b3a00040a4e	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1adb7a28-9dc6-3f8b-e063-6394a90a9335	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Aurobindo Pharma Limited	8d142533-4e87-4030-8fe9-4fc7473b0442	2023-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218122 application number: ANDA218122

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-686-20	72189068620	20 CAPSULE in 1 BOTTLE (72189-686-20)	20 capsule	2026-08-25	No	No	Current