Loperamide Hydrochloride

Product NDC: 0093-0311
11-digit product format: 000930311
Labeler code: 0093
Product ID: 0093-0311_863c19d4-c0cd-455e-9a93-5c5157762d02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		1992-04-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A073192-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (product): 0093-0311

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
8bf47ac3-746f-47c3-82b2-32ac979ff963	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
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-0311-01	Loperamide Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		14
0093-0311-05	Loperamide Hydrochloride	500 in 1 BOTTLE	CAPSULE	500		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0311-01	EA - Each	0093-0311	d6a41274-405d-4456-b54a-6b6712ab469e	1	2012-07-24
0093-0311-05	EA - Each	0093-0311	4f8a86f1-1ad3-4e0f-aa13-34dc31d101bf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]	3
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
Loperamide Hydrochloride	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
Loperamide	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
IRON	INACTIVE INGREDIENT	E1UOL152H7	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0311	LOPERAMIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20210818_8bf47ac3-746f-47c3-82b2-32ac979ff963.zip

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	865cf4c7-f643-451b-b0d4-d30bda621f7d	105
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	865cf4c7-f643-451b-b0d4-d30bda621f7d	105
978006	loperamide HCl 2 MG Oral Capsule	PSN	3310a3c2-389a-4b27-a478-67c905789854	20
978006	loperamide HCl 2 MG Oral Capsule	PSN	580e6cd4-3f05-4996-9dc3-c50d757ae210	20
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3310a3c2-389a-4b27-a478-67c905789854	20
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	580e6cd4-3f05-4996-9dc3-c50d757ae210	20
978006	loperamide HCl 2 MG Oral Capsule	PSN	8bf47ac3-746f-47c3-82b2-32ac979ff963	14
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	8bf47ac3-746f-47c3-82b2-32ac979ff963	14
978006	loperamide HCl 2 MG Oral Capsule	PSN	97c37571-9116-40d6-ba07-f4a5a8d9b689	13
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	97c37571-9116-40d6-ba07-f4a5a8d9b689	13
978006	loperamide HCl 2 MG Oral Capsule	PSN	d358a9c1-47fa-424c-8cc0-24010cfb7ee3	8
978006	loperamide HCl 2 MG Oral Capsule	PSN	42989f90-8ff5-44d1-a462-28c18ce02738	8
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	d358a9c1-47fa-424c-8cc0-24010cfb7ee3	8
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	42989f90-8ff5-44d1-a462-28c18ce02738	8
978006	loperamide HCl 2 MG Oral Capsule	PSN	3e898141-8d40-49f1-e054-00144ff88e88	6
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3e898141-8d40-49f1-e054-00144ff88e88	6
978006	loperamide HCl 2 MG Oral Capsule	PSN	3fcb106c-f72e-17d9-e054-00144ff8d46c	5
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3fcb106c-f72e-17d9-e054-00144ff8d46c	5
978006	loperamide HCl 2 MG Oral Capsule	PSN	3d23f73b-afc2-448d-afb3-b167d02cfc06	3
978006	loperamide HCl 2 MG Oral Capsule	PSN	af0b886f-c065-26dc-e053-2995a90ac471	3
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3d23f73b-afc2-448d-afb3-b167d02cfc06	3
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	af0b886f-c065-26dc-e053-2995a90ac471	3
978006	loperamide HCl 2 MG Oral Capsule	PSN	5c2f4b11-6c45-4270-9b0b-ce73d5eae65f	2
978006	loperamide HCl 2 MG Oral Capsule	PSN	ab07bfd1-d2d3-427a-866d-89a10d40a4e9	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	5c2f4b11-6c45-4270-9b0b-ce73d5eae65f	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	ab07bfd1-d2d3-427a-866d-89a10d40a4e9	2
978006	loperamide HCl 2 MG Oral Capsule	PSN	59a421cf-dfaa-6685-e053-2a91aa0a9b3f	1
978006	loperamide HCl 2 MG Oral Capsule	PSN	a64b9fed-bf27-4e02-876e-72a628a0d8ef	1
978006	loperamide HCl 2 MG Oral Capsule	PSN	c97152f0-73ae-4463-8177-8f9250d84252	1
978006	loperamide HCl 2 MG Oral Capsule	PSN	45a1e6b0-1e2b-958a-e063-6394a90a261d	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	a64b9fed-bf27-4e02-876e-72a628a0d8ef	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	59a421cf-dfaa-6685-e053-2a91aa0a9b3f	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	c97152f0-73ae-4463-8177-8f9250d84252	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	Marketing end	Sample	Exclude flag	Status
0093-0311-01	00093031101	100 CAPSULE in 1 BOTTLE (0093-0311-01)	100 capsule	1993-05-01	0000-00-00	No	No	Current
0093-0311-05	00093031105	500 CAPSULE in 1 BOTTLE (0093-0311-05)	500 capsule	1993-05-01	0000-00-00	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
Loperamide Hydrochloride Capsules USP 8422901/0717 Rx only	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	8
Loperamide Hydrochloride Capsules USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	20
Loperamide Hydrochloride Capsules USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	20
Loperamide Hydrochloride Capsules USP Rx only	A-S Medication Solutions	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	13
Loperamide Hydrochloride Capsules USP Rx only	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	105
LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only	NuCare Pharmaceuticals, Inc.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	6
Loperamide Hydrochloride Capsules USP Rx only	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Loperamide Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	5
Loperamide Hydrochloride Capsules USP Rx only	REMEDYREPACK INC.	2024-01-03	HUMAN PRESCRIPTION DRUG LABEL	13
LOPERAMIDE HYDROCHLORIDE	DIRECT RX	2023-04-20	HUMAN PRESCRIPTION DRUG LABEL	8
Loperamide Hydrochloride Capsules USP Rx only	Bryant Ranch Prepack	2022-02-01	HUMAN PRESCRIPTION DRUG LABEL	1013
Loperamide Hydrochloride Capsules USP Rx only	QPharma Inc \| Teva Pharmaceuticals USA, Inc. \| Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	3
Loperamide Hydrochloride Capsules USP Rx only	Bryant Ranch Prepack	2020-05-22	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride Capsules USP Rx only	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride Capsules USP Rx only	NuCare Pharmaceuticals,Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Loperamide Hydrochloride Capsules USP Rx only	REMEDYREPACK INC.	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL	8
Loperamide Hydrochloride Capsules USP Rx only	Bryant Ranch Prepack	2019-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride Capsules USP Rx only	Preferred Pharmaceuticals, Inc.	2018-11-28	HUMAN PRESCRIPTION DRUG LABEL	5
Loperamide Hydrochloride Capsules USP 454 Rx only	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-20	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride Capsules USP Rx only	NuCare pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2017-08-31	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride Capsules USP Rx only	Teva Pharmaceuticals USA, Inc.	2016-11-30	HUMAN PRESCRIPTION DRUG LABEL	14
LOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2016-09-06	HUMAN PRESCRIPTION DRUG LABEL	2