Anti Diarrheal

Product NDC: 49035-375
11-digit product format: 490350375
Labeler code: 49035
Product ID: 49035-375_538699b9-0857-4b0a-8a4f-faee4a5e21a8
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: ANDA076497
Marketing category: ANDA
Marketing start: 2005-05-03
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Anti Diarrheal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	77TI35393C
Rxcui	978010

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
49035-375-08	Anti Diarrheal	6 in 1 CARTON	TABLET	6		13
49035-375-38	Anti Diarrheal	4 in 1 BLISTER PACK	TABLET	4		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-375-08	EA - Each	49035-375	961b52c8-bce9-49f3-9ca0-dad9f03558c1	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-375	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [WAL-MART STORES INC]	12	Current NDC, Legacy NDC, 2 package rows	20250512_b480916e-6383-468d-9e3e-499efea92522.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	b480916e-6383-468d-9e3e-499efea92522	13
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	b480916e-6383-468d-9e3e-499efea92522	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-375-08	49035037508	6 BLISTER PACK in 1 CARTON (49035-375-08) / 4 TABLET in 1 BLISTER PACK (49035-375-38)	6 blister pack	2005-05-03	0000-00-00	No	No	Current
49035-375-38	49035037538	4 in 1 BLISTER PACK						Historical