FDA.reportPublic FDA data

cephalexin

Product NDC
68180-441
11-digit product format
681800441
Labeler code
68180
Product ID
68180-441_78aee1aa-f859-489e-98b5-78af55b92374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065234
Marketing category
ANDA
Marketing start
2017-09-06
Substance
CEPHALEXIN
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309110, 309113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-441-01cephalexin100 mL in 1 BOTTLEFOR SUSPENSION10013
68180-441-02cephalexin200 mL in 1 BOTTLEFOR SUSPENSION20013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-441-01ML - Milliliter68180-44195633af9-4c07-4baa-a9c2-ca5b8ac542f712017-10-13
68180-441-02ML - Milliliter68180-4416b28f6b4-6a38-4ca5-ad84-1b4dd026b06312017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-441CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20240817_25ef498a-7a7e-4543-a544-b9d0e99f9cd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN553485f8-890d-4929-a6bb-905221cf411d3
309113cephalexin 50 MG/ML Oral SuspensionSCD553485f8-890d-4929-a6bb-905221cf411d3
309113cefalexin 50 MG/ML Oral SuspensionSY553485f8-890d-4929-a6bb-905221cf411d3
309113cephalexin 250 MG per 5 ML Oral SuspensionSY553485f8-890d-4929-a6bb-905221cf411d3
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN829244bd-93da-4a5a-a257-890cfec4c06d2
309113cephalexin 50 MG/ML Oral SuspensionSCD829244bd-93da-4a5a-a257-890cfec4c06d2
309113cefalexin 50 MG/ML Oral SuspensionSY829244bd-93da-4a5a-a257-890cfec4c06d2
309113cephalexin 250 MG per 5 ML Oral SuspensionSY829244bd-93da-4a5a-a257-890cfec4c06d2
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN0a24b6e5-6f13-44b4-93f4-47c86945cad21
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNf4d822bb-8b52-8f74-e053-2a95a90aa4bb1
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNd31da5be-c939-4aa0-adb8-b26a1396b2281
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN141bd050-5dfc-68fa-e063-6394a90a6d861
309113cephalexin 50 MG/ML Oral SuspensionSCD141bd050-5dfc-68fa-e063-6394a90a6d861
309113cephalexin 50 MG/ML Oral SuspensionSCDd31da5be-c939-4aa0-adb8-b26a1396b2281
309113cephalexin 50 MG/ML Oral SuspensionSCD0a24b6e5-6f13-44b4-93f4-47c86945cad21
309113cephalexin 50 MG/ML Oral SuspensionSCDf4d822bb-8b52-8f74-e053-2a95a90aa4bb1
309113cefalexin 50 MG/ML Oral SuspensionSY141bd050-5dfc-68fa-e063-6394a90a6d861
309113cefalexin 50 MG/ML Oral SuspensionSYd31da5be-c939-4aa0-adb8-b26a1396b2281
309113cefalexin 50 MG/ML Oral SuspensionSY0a24b6e5-6f13-44b4-93f4-47c86945cad21
309113cefalexin 50 MG/ML Oral SuspensionSYf4d822bb-8b52-8f74-e053-2a95a90aa4bb1
309113cephalexin 250 MG per 5 ML Oral SuspensionSY141bd050-5dfc-68fa-e063-6394a90a6d861
309113cephalexin 250 MG per 5 ML Oral SuspensionSY0a24b6e5-6f13-44b4-93f4-47c86945cad21
309113cephalexin 250 MG per 5 ML Oral SuspensionSYd31da5be-c939-4aa0-adb8-b26a1396b2281
309113cephalexin 250 MG per 5 ML Oral SuspensionSYf4d822bb-8b52-8f74-e053-2a95a90aa4bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-441-0168180044101100 mL in 1 BOTTLE (68180-441-01) 100 ml2017-09-290000-00-00NoNoCurrent
68180-441-0268180044102200 mL in 1 BOTTLE (68180-441-02) 200 ml2017-09-060000-00-00NoNoCurrent