cephalexin

Product NDC: 68180-123
11-digit product format: 681800123
Labeler code: 68180
Product ID: 68180-123_b456b5a9-f268-4ccf-8dde-ac001a2961a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA065234
Marketing category: ANDA
Marketing start: 2006-01-11
Marketing end: 2020-01-01
Substance: CEPHALEXIN
Active strength: 125 mg/5mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
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
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-123-01	cephalexin	100 mL in 1 BOTTLE	FOR SUSPENSION	100		13
68180-123-02	cephalexin	200 mL in 1 BOTTLE	FOR SUSPENSION	200		13

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-123-01	ML - Milliliter	68180-123	dc37e527-d07a-4c3b-8749-d9f279405115	1	2012-07-24
68180-123-02	ML - Milliliter	68180-123	6d1eb0e2-a2f6-4d15-aa5d-e3d3203c3df6	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-123	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	10	Legacy NDC, 2 package rows	20240817_25ef498a-7a7e-4543-a544-b9d0e99f9cd9.zip

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68180-123-01	68180012301	100 mL in 1 BOTTLE	100 ml	Historical
68180-123-02	68180012302	200 mL in 1 BOTTLE	200 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
cephalexin	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	14