Loperamide Hydrochloride

Product NDC: 70518-3400
11-digit product format: 705183400
Labeler code: 70518
Product ID: 70518-3400_eedb03c8-3689-5824-e053-2995a90ac55e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loperamide hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA215579
Marketing category: ANDA
Marketing start: 2022-04-04
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-3400		D	Discontinued by firm	2026-08-07
excluded package	package	70518-3400	70518-3400-0	D	Discontinued by firm	2026-08-07
excluded package	package	70518-3400	70518-3400-1	D	Discontinued by firm	2026-08-07
excluded package	package	70518-3400	70518-3400-2	D	Discontinued by firm	2026-08-07
excluded package	package	70518-3400	70518-3400-3	D	Discontinued by firm	2026-08-07
excluded package	package	70518-3400	70518-3400-4	D	Discontinued by firm	2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3400	70518-3400-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3400	70518-3400-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A215579-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2021-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215579-001	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
2026-02-19 14:30 UTC	2026-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`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	A215579-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215579-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215579-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215579-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215579-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215579-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215579-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215579-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215579-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215579-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215579-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215579-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215579-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215579-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215579-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215579-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215579-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215579-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215579-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215579-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215579-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215579-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215579-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215579-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215579-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215579-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215579-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215579-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215579-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215579-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215579-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215579-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215579-001	AB	1	`a50c72e98297…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3400	LOPERAMIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	6	Legacy NDC	20240927_e3d3f75a-272b-4c85-804f-b04544ae90e7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	AvPAK	f8992723-dd9a-bcf6-e053-6294a90aa65c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4e7076-fd25-aeb8-e053-2995a90a2aa0	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	691c5dd6-b85d-482b-a8c1-8c4b48b48dc9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	6e60cb25-6af9-4f17-b740-a5e7b5bb2a09	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579

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	Marketing end	Sample	Exclude flag	Status
70518-3400-0	70518340000	30 CAPSULE in 1 BLISTER PACK (70518-3400-0)	30 capsule	2022-04-04	0000-00-00	No	No	Current
70518-3400-1	70518340001	10 CAPSULE in 1 BLISTER PACK (70518-3400-1)	10 capsule	2022-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride Capsules, USP Rx only	REMEDYREPACK INC.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	7