Candesartan cilexetil

Product NDC: 0781-5938
11-digit product format: 007815938
Labeler code: 0781
Product ID: 0781-5938_ac55d9f4-5280-47ba-bc37-80c26e708525
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Candesartan cilexetil
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA078702
Marketing category: ANDA
Marketing start: 2013-05-21
Marketing end: 2020-09-30
Substance: CANDESARTAN CILEXETIL
Active strength: 16 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
03f056e9-4354-02cc-6010-79c6c9eaac0a	Product name	6	20250521
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5938-31	EA - Each	0781-5938	4f34bd64-1db7-4409-91f9-3f79fae4e39c	1	2013-06-04
0781-5938-92	EA - Each	0781-5938	fa753fe9-686e-4b1c-a1b9-df3e65d7016e	1	2013-06-04

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CANDESARTAN CILEXETIL	ACTIVE INGREDIENT	R85M2X0D68	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
CANDESARTAN	ACTIVE MOIETY	S8Q36MD2XX	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R85M2X0D68	CANDESARTAN CILEXETIL	145040-37-5	CANDESARTAN CILEXETIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577776	candesartan cilexetil 16 MG Oral Tablet	PSN	a67f4f53-76c7-4239-9dd6-fef8e8019e9a	3
577776	candesartan cilexetil 16 MG Oral Tablet	SCD	a67f4f53-76c7-4239-9dd6-fef8e8019e9a	3