Loperamide Hydrochloride

Product NDC: 0378-2100
11-digit product format: 003782100
Labeler code: 0378
Product ID: 0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loperamide hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA072741
Marketing category: ANDA
Marketing start: 1991-09-18
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 42.

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
A072741-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072741-001	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.

Product history page 1 of 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072741-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072741-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072741-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072741-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072741-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072741-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072741-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072741-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072741-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072741-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072741-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072741-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072741-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072741-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072741-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072741-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072741-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072741-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072741-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072741-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072741-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072741-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072741-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072741-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072741-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072741-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072741-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072741-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072741-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072741-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072741-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072741-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072741-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072741-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072741-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072741-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072741-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072741-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072741-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072741-001	AB	1	`e64feba35796…`

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
72a7ae47-cdf3-4949-b9f8-f29b153f787f	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	Strength	SPL version
0378-2100-01	Loperamide Hydrochloride	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		14
0378-2100-05	Loperamide Hydrochloride	500 in 1 BOTTLE, PLASTIC	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
0378-2100-01	EA - Each	0378-2100	ca068534-a324-46e4-bbda-b35d56273757	1	2012-07-24
0378-2100-05	EA - Each	0378-2100	433d8e40-7961-4938-addc-0fe8e6909fbc	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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	7
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2100	LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	14	Current NDC, Legacy NDC, 2 package rows	20240111_72a7ae47-cdf3-4949-b9f8-f29b153f787f.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 · 7 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	be99224e-dd49-4628-a5bf-ed8469ffd4a4	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	74b9893a-18c3-4117-85c2-edab8e7b3b3b	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Safecor Health LLC	8b0ac05b-90c1-476b-b001-5801dd21701d	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Institutional Inc.	ad71d4ab-d293-47a2-8f3f-2c9f42d76e40	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c5322892-cb14-4a25-9b42-e62e491bc101	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	f092b8a5-80b0-40ba-af45-2ac9edaa7704	2023-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	72a7ae47-cdf3-4949-b9f8-f29b153f787f	2022-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741 ndc (product): 0378-2100

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	f092b8a5-80b0-40ba-af45-2ac9edaa7704	103
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	f092b8a5-80b0-40ba-af45-2ac9edaa7704	103
978006	loperamide HCl 2 MG Oral Capsule	PSN	ad71d4ab-d293-47a2-8f3f-2c9f42d76e40	17
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	ad71d4ab-d293-47a2-8f3f-2c9f42d76e40	17
978006	loperamide HCl 2 MG Oral Capsule	PSN	72a7ae47-cdf3-4949-b9f8-f29b153f787f	14
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	72a7ae47-cdf3-4949-b9f8-f29b153f787f	14
978006	loperamide HCl 2 MG Oral Capsule	PSN	5dd31d61-7081-4895-8321-a77b439d7d2c	4
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	5dd31d61-7081-4895-8321-a77b439d7d2c	4
978006	loperamide HCl 2 MG Oral Capsule	PSN	8b0ac05b-90c1-476b-b001-5801dd21701d	3
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	8b0ac05b-90c1-476b-b001-5801dd21701d	3
978006	loperamide HCl 2 MG Oral Capsule	PSN	6deb0658-c96e-40bd-b3a3-9655a4769270	2
978006	loperamide HCl 2 MG Oral Capsule	PSN	a66d2f97-8d22-482d-b18b-f58f1d882f42	2
978006	loperamide HCl 2 MG Oral Capsule	PSN	59a44282-30f2-103b-e053-2a91aa0a643a	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	a66d2f97-8d22-482d-b18b-f58f1d882f42	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	6deb0658-c96e-40bd-b3a3-9655a4769270	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	59a44282-30f2-103b-e053-2a91aa0a643a	2
978006	loperamide HCl 2 MG Oral Capsule	PSN	c5322892-cb14-4a25-9b42-e62e491bc101	1
978006	loperamide HCl 2 MG Oral Capsule	PSN	3fc80822-6256-4937-e054-00144ff8d46c	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3fc80822-6256-4937-e054-00144ff8d46c	1
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	c5322892-cb14-4a25-9b42-e62e491bc101	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2100-01	00378210001	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01)	100 capsule	1991-09-18	0000-00-00	No	No	Current
0378-2100-05	00378210005	500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05)	500 capsule	1991-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	3
Loperamide Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	17
Loperamide Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	14
Loperamide Hydrochloride Capsules, USP 2 mg	NCS HealthCare of KY, LLC dba Vangard Labs	2023-11-16	HUMAN PRESCRIPTION DRUG LABEL	4
Loperamide Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2023-08-10	HUMAN PRESCRIPTION DRUG LABEL	10
Loperamide Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2023-05-24	HUMAN PRESCRIPTION DRUG LABEL	103
Loperamide Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2022-09-30	HUMAN PRESCRIPTION DRUG LABEL	14
Loperamide Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
Loperamide 2 mg 456	Contract Pharmacy Services-PA \| Coupler Enterprises	2018-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
Loperamide Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2018-08-29	HUMAN PRESCRIPTION DRUG LABEL	4
Loperamide Hydrochloride Capsules, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2017-01-09	HUMAN PRESCRIPTION DRUG LABEL	9
Loperamide Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2016-04-13	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-09-18	HUMAN PRESCRIPTION DRUG LABEL	2