Loperamide Hydrochloride Capsules, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-06-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:51:01

Label at a glance#

ProductLoperamide hydrochloride

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loperamide hydrochloride capsules USP, 2 mg

NDC 70771-1769-1

100 capsules

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978006	loperamide HCl 2 MG Oral Capsule	PSN	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LOPERAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1769-1	Loperamide hydrochloride	100 in 1 BOTTLE	CAPSULE	100	1
70771-1769-2	Loperamide hydrochloride	10 in 1 BLISTER PACK	CAPSULE	10	1
70771-1769-4	Loperamide hydrochloride	10 in 1 CARTON	CAPSULE	10	1
70771-1769-5	Loperamide hydrochloride	500 in 1 BOTTLE	CAPSULE	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1769	LOPERAMIDE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 4 package rows	20230625_5d13405c-8fd7-454f-9b49-3d8b9ef672b8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Loperamide hydrochloride
LOPERAMIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POTASSIUM HYDROXIDE
POVIDONE K30
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1769	70771-1769-1, 70771-1769-5, 70771-1769-2, 70771-1769-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
GELATIN	2G86QN327L	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE 101	7T9FYH5QMK	IACT
MICROCRYSTALLINE CELLULOSE 102	PNR0YF693Y	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
POVIDONE K30	U725QWY32X	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A217471-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2023-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217471-001	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
2026-10-15 13:18:30	2026-09	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217471-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-03-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A217471-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217471-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217471-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217471-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217471-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217471-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217471-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217471-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217471-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217471-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217471-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217471-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217471-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217471-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217471-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217471-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217471-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217471-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217471-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217471-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217471-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217471-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217471-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217471-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A217471-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217471-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zydus Lifesciences Limited	5d13405c-8fd7-454f-9b49-3d8b9ef672b8	2023-06-19		Exact identifier ndc (package): 70771-1769-1 ndc (package): 70771-1769-2 ndc (package): 70771-1769-4 ndc (package): 70771-1769-5 ndc (product): 70771-1769 ndc11 (package): 70771176901 ndc11 (package): 70771176905 ndc11 (package): 70771176902 ndc11 (package): 70771176904 spl id: b43ff8ed-7175-4a7a-8e42-5c66324b495c spl set id: 5d13405c-8fd7-454f-9b49-3d8b9ef672b8

Reported adverse events (FAERS/openFDA)#

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