Amiloride Hydrochloride

Product NDC: 68151-0162
11-digit product format: 681510162
Labeler code: 68151
Product ID: 68151-0162_3755be8b-624b-4bc4-958b-505220694dc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiloride Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA070346
Marketing category: ANDA
Marketing start: 1986-01-22
Marketing end: 0000-00-00
Substance: AMILORIDE HYDROCHLORIDE ANHYDROUS
Active strength: 5 mg/1
Pharmacologic classes: Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7954898a-d540-405e-aa1d-3553358552e5	Product name	1	20150812

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-0162-0	2020-01-31	C162847	48780-1	9d75b9d0-8ca4-f424-e053-dadaa90a57ce	875f3f5a-ed45-4646-8537-21f054302d6f

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0162-0	Amiloride Hydrochloride	1 in 1 PACKAGE	TABLET	1		4

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMILORIDE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	7M458Q65S3	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
AMILORIDE	ACTIVE MOIETY	7DZO8EB0Z3	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0162	AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_875f3f5a-ed45-4646-8537-21f054302d6f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7M458Q65S3	AMILORIDE HYDROCHLORIDE ANHYDROUS	2016-88-8	AMILORIDE HYDROCHLORIDE ANHYDROUS
FZJ37245UC	AMILORIDE HYDROCHLORIDE	17440-83-4	Amiloride Hydrochloride

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
977880	aMILoride HCl 5 MG Oral Tablet	PSN	875f3f5a-ed45-4646-8537-21f054302d6f	4
977880	amiloride hydrochloride 5 MG Oral Tablet	SCD	875f3f5a-ed45-4646-8537-21f054302d6f	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-0162-0	68151016200	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amiloride Hydrochloride - Carilion Materials Management	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4