LOPERAMIDE HYDROCHLORIDE

Product NDC: 70518-4283
Requested package NDC: 70518-4283-2
11-digit product format: 705184283
Labeler code: 70518
Product ID: 70518-4283_58786381-0bef-7a0c-e063-6394a90a99c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LOPERAMIDE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA218122
Marketing category: ANDA
Marketing start: 2025-02-10
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 HYDROCHLORIDE
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
3fdfc0e5-56a2-48a0-8ee6-390a194a29f3	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	SPL version
70518-4283-0	LOPERAMIDE HYDROCHLORIDE	30 in 1 BLISTER PACK	CAPSULE	30	5
70518-4283-1	LOPERAMIDE HYDROCHLORIDE	30 in 1 BLISTER PACK	CAPSULE	30	5
70518-4283-2	LOPERAMIDE HYDROCHLORIDE	15 in 1 BLISTER PACK	CAPSULE	15	5
70518-4283-3	LOPERAMIDE HYDROCHLORIDE	10 in 1 BLISTER PACK	CAPSULE	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4283	LOPERAMIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	4	Current NDC, 4 package rows	20250417_3fdfc0e5-56a2-48a0-8ee6-390a194a29f3.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 · 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
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 ndc (package): 70518-4283-2 ndc (product): 70518-4283 ndc11 (package): 70518428302
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978006	loperamide HCl 2 MG Oral Capsule	PSN	3fdfc0e5-56a2-48a0-8ee6-390a194a29f3	5
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3fdfc0e5-56a2-48a0-8ee6-390a194a29f3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4283-2	70518428302	15 CAPSULE in 1 BLISTER PACK (70518-4283-2)	15 capsule	2025-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride Capsules, USP Rx only	REMEDYREPACK INC.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	7