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 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
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.

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`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	A073192-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073192-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073192-001	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
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

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 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

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