Cephalexin

Product NDC: 68180-121
11-digit product format: 681800121
Labeler code: 68180
Product ID: 68180-121_06fa2abb-0eee-4425-8063-b9dfe56c1867
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA065229
Marketing category: ANDA
Marketing start: 2006-01-11
Substance: CEPHALEXIN
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Cephalexin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	250 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	OBN7UDS42Y
Rxcui	309112, 309114

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-121-01	Cephalexin	100 in 1 BOTTLE	CAPSULE	100		9
68180-121-02	Cephalexin	500 in 1 BOTTLE	CAPSULE	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-121-01	EA - Each	68180-121	9866e5fe-960d-4bfc-98b4-99ad81b01db9	1	2012-07-24
68180-121-02	EA - Each	68180-121	f04bbb56-419d-4f0e-91f6-08ae99c95947	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FERRIC OXIDE BLACK	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-121	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20201230_1d3e6d33-5dc2-498e-8efa-e3c4fca15dff.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
309112	cephalexin 250 MG Oral Capsule	PSN	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309112	cephalexin 250 MG Oral Capsule	PSN	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309114	cephalexin 500 MG Oral Capsule	PSN	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309114	cephalexin 500 MG Oral Capsule	PSN	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309112	cephalexin 250 MG Oral Capsule	SCD	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309112	cephalexin 250 MG Oral Capsule	SCD	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309114	cephalexin 500 MG Oral Capsule	SCD	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309114	cephalexin 500 MG Oral Capsule	SCD	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309112	cephalexin 250 MG Oral Capsule	PSN	728c5212-dbd8-8df5-e053-2a91aa0a9579	4
309112	cephalexin 250 MG Oral Capsule	SCD	728c5212-dbd8-8df5-e053-2a91aa0a9579	4
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	728c5212-dbd8-8df5-e053-2a91aa0a9579	4
309112	cephalexin 250 MG Oral Capsule	PSN	c5f1a7f6-a5a4-48f1-9022-d6d402bfd349	3
309112	cephalexin 250 MG Oral Capsule	PSN	a33280d4-7caf-f74b-e053-2a95a90a90c3	3
309112	cephalexin 250 MG Oral Capsule	SCD	c5f1a7f6-a5a4-48f1-9022-d6d402bfd349	3
309112	cephalexin 250 MG Oral Capsule	SCD	a33280d4-7caf-f74b-e053-2a95a90a90c3	3
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	a33280d4-7caf-f74b-e053-2a95a90a90c3	3
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	c5f1a7f6-a5a4-48f1-9022-d6d402bfd349	3
309112	cephalexin 250 MG Oral Capsule	PSN	ebf9dd58-a494-45a9-9ed3-a89887817193	2
309112	cephalexin 250 MG Oral Capsule	PSN	36e8f074-067e-4485-9386-d52d7faed5ab	2
309112	cephalexin 250 MG Oral Capsule	SCD	36e8f074-067e-4485-9386-d52d7faed5ab	2
309112	cephalexin 250 MG Oral Capsule	SCD	ebf9dd58-a494-45a9-9ed3-a89887817193	2
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	ebf9dd58-a494-45a9-9ed3-a89887817193	2
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	36e8f074-067e-4485-9386-d52d7faed5ab	2
309112	cephalexin 250 MG Oral Capsule	PSN	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309114	cephalexin 500 MG Oral Capsule	PSN	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309112	cephalexin 250 MG Oral Capsule	SCD	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309114	cephalexin 500 MG Oral Capsule	SCD	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	6032b68f-16d8-41b6-bd2c-86d5406a757a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-121-01	68180012101	100 CAPSULE in 1 BOTTLE (68180-121-01)	100 capsule	2006-11-01	0000-00-00	No	No	Current
68180-121-02	68180012102	500 CAPSULE in 1 BOTTLE (68180-121-02)	500 capsule	2006-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	9
Cephalexin	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Cephalexin	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
Cephalexin	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	9
Cephalexin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-09-21	HUMAN PRESCRIPTION DRUG LABEL	1
CEPHALEXIN CAPSULES USP	Blenheim Pharmacal, Inc.	2013-06-04	HUMAN PRESCRIPTION DRUG LABEL	2
CEPHALEXIN CAPSULES USP	TYA Pharmaceuticals	2012-09-17	HUMAN PRESCRIPTION DRUG LABEL	2
CEPHALEXIN CAPSULES USP	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	3

Cephalexin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

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#