cephalexin

Product NDC: 62756-294
11-digit product format: 627560294
Labeler code: 62756
Product ID: 62756-294_ec678657-42f1-4a51-a596-129033e2ff60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries Limited
Application: ANDA062791
Marketing category: ANDA
Marketing start: 2010-06-21
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 500 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62756-294-13	2019-10-21	C162847	48780-1	956f9ecf-bce2-621f-e053-dbdaa90a74ad	Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
62756-294-88	2019-10-21	C162847	48780-1	956f9ecf-bce2-621f-e053-dbdaa90a74ad	Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62756-294-13	cephalexin	500 in 1 BOTTLE	CAPSULE	500		1
62756-294-88	cephalexin	100 in 1 BOTTLE	CAPSULE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-294-13	EA - Each	62756-294	b46c1fe5-d1ab-4b01-93e6-cc1b4b4ef30a	1	2012-07-24
62756-294-88	EA - Each	62756-294	1edac3d2-c4fb-482b-910c-a98659dba85f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	5
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	4
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
CEPHALEXIN ANHYDROUS	ACTIVE INGREDIENT	5SFF1W6677	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	3
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [DIRECT RX]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [DIRECT RX]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [DIRECT RX]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [DIRECT RX]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [DIRECT RX]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP]	2
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CEPHALEXIN	ACTIVE MOIETY	OBN7UDS42Y	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-294	CEPHALEXIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	1	Legacy NDC, 2 package rows	20100621_ec678657-42f1-4a51-a596-129033e2ff60.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OBN7UDS42Y	CEPHALEXIN	23325-78-2	CEPHALEXIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309114	cephalexin 500 MG Oral Capsule	PSN	9fe6fa13-c357-4c6b-83f8-33f74ce0ebdc	5
309114	cephalexin 500 MG Oral Capsule	SCD	9fe6fa13-c357-4c6b-83f8-33f74ce0ebdc	5
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	9fe6fa13-c357-4c6b-83f8-33f74ce0ebdc	5
309114	cephalexin 500 MG Oral Capsule	PSN	6abc40af-be15-405e-845c-c31866b3d6f6	4
309114	cephalexin 500 MG Oral Capsule	PSN	d6b3940f-a296-44a4-adf2-9e396909add2	4
309114	cephalexin 500 MG Oral Capsule	SCD	6abc40af-be15-405e-845c-c31866b3d6f6	4
309114	cephalexin 500 MG Oral Capsule	SCD	d6b3940f-a296-44a4-adf2-9e396909add2	4
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	d6b3940f-a296-44a4-adf2-9e396909add2	4
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	6abc40af-be15-405e-845c-c31866b3d6f6	4
309112	cephalexin 250 MG Oral Capsule	PSN	cab0d668-f4a4-4848-ba93-fa2c2246096c	3
309114	cephalexin 500 MG Oral Capsule	PSN	981e3b45-0fd0-4198-a6e0-fead314c85a9	3
309114	cephalexin 500 MG Oral Capsule	PSN	cab0d668-f4a4-4848-ba93-fa2c2246096c	3
309112	cephalexin 250 MG Oral Capsule	SCD	cab0d668-f4a4-4848-ba93-fa2c2246096c	3
309114	cephalexin 500 MG Oral Capsule	SCD	cab0d668-f4a4-4848-ba93-fa2c2246096c	3
309114	cephalexin 500 MG Oral Capsule	SCD	981e3b45-0fd0-4198-a6e0-fead314c85a9	3
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	981e3b45-0fd0-4198-a6e0-fead314c85a9	3
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	cab0d668-f4a4-4848-ba93-fa2c2246096c	3
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	cab0d668-f4a4-4848-ba93-fa2c2246096c	3
309114	cephalexin 500 MG Oral Capsule	PSN	c5604b48-d58f-45ac-8602-72241ed4b906	2
309114	cephalexin 500 MG Oral Capsule	SCD	c5604b48-d58f-45ac-8602-72241ed4b906	2
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	c5604b48-d58f-45ac-8602-72241ed4b906	2
309112	cephalexin 250 MG Oral Capsule	PSN	ec678657-42f1-4a51-a596-129033e2ff60	1
309114	cephalexin 500 MG Oral Capsule	PSN	b8d005fe-4cb7-4c65-8848-107f3985e4b8	1
309114	cephalexin 500 MG Oral Capsule	PSN	ec678657-42f1-4a51-a596-129033e2ff60	1
309112	cephalexin 250 MG Oral Capsule	SCD	ec678657-42f1-4a51-a596-129033e2ff60	1
309114	cephalexin 500 MG Oral Capsule	SCD	b8d005fe-4cb7-4c65-8848-107f3985e4b8	1
309114	cephalexin 500 MG Oral Capsule	SCD	ec678657-42f1-4a51-a596-129033e2ff60	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	b8d005fe-4cb7-4c65-8848-107f3985e4b8	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	ec678657-42f1-4a51-a596-129033e2ff60	1
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	ec678657-42f1-4a51-a596-129033e2ff60	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
62756-294-13	62756029413	500 in 1 BOTTLE	Historical
62756-294-88	62756029488	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEPHALEXIN	DIRECT RX	2016-11-07	HUMAN PRESCRIPTION DRUG LABEL	4
cephalexin	Blenheim Pharmacal, Inc.	2015-03-23	HUMAN PRESCRIPTION DRUG LABEL	5
cephalexin	Preferred Pharmaceuticals, Inc. \| Preferred Pharmaceutical, Inc.	2014-10-08	HUMAN PRESCRIPTION DRUG LABEL	3
cephalexin	State of Florida DOH Central Pharmacy	2013-09-09	HUMAN PRESCRIPTION DRUG LABEL	1
cephalexin	Aidarex Pharmaceuticals LLC	2012-09-13	HUMAN PRESCRIPTION DRUG LABEL	3
cephalexin	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
cephalexin	Unit Dose Services	2010-06-14	Human Prescription Drug Label	4
cephalexin	Sun Pharmaceutical Industries Limited	2010-06-14	Human Prescription Drug Label	1

cephalexin

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#