FDA.reportPublic FDA data

Cephalexin

Product NDC
68180-122
11-digit product format
681800122
Labeler code
68180
Product ID
68180-122_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
500 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
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112, 309114

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-122-01Cephalexin100 in 1 BOTTLECAPSULE1009
68180-122-02Cephalexin500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-122-01EA - Each68180-122a2495790-6fb4-4105-9de8-a9cfc744041012012-07-24
68180-122-02EA - Each68180-1224dc74036-2d8e-4d27-a6a9-55f55f4873e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-122CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20201230_1d3e6d33-5dc2-498e-8efa-e3c4fca15dff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNaf10128f-021a-14b7-e053-2a95a90a436512
309114cephalexin 500 MG Oral CapsuleSCDaf10128f-021a-14b7-e053-2a95a90a436512
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf10128f-021a-14b7-e053-2a95a90a436512
309114cephalexin 500 MG Oral CapsulePSNb3bb8222-161e-4d9c-8e08-7e22ad65bf7211
309114cephalexin 500 MG Oral CapsuleSCDb3bb8222-161e-4d9c-8e08-7e22ad65bf7211
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb3bb8222-161e-4d9c-8e08-7e22ad65bf7211
309114cephalexin 500 MG Oral CapsulePSNdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309114cephalexin 500 MG Oral CapsuleSCDdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309112cephalexin 250 MG Oral CapsulePSNec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin 250 MG Oral CapsulePSN1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cephalexin 500 MG Oral CapsulePSN1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cephalexin 500 MG Oral CapsulePSNec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin 250 MG Oral CapsuleSCD1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309112cephalexin 250 MG Oral CapsuleSCDec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cephalexin 500 MG Oral CapsuleSCDec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cephalexin 500 MG Oral CapsuleSCD1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cephalexin 500 MG Oral CapsulePSNaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cephalexin 500 MG Oral CapsuleSCDaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cephalexin 500 MG Oral CapsulePSN8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cephalexin 500 MG Oral CapsuleSCD8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cephalexin 500 MG Oral CapsulePSN6440351e-065f-59da-e053-2a91aa0aa4c55
309114cephalexin 500 MG Oral CapsuleSCD6440351e-065f-59da-e053-2a91aa0aa4c55
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6440351e-065f-59da-e053-2a91aa0aa4c55
309114cephalexin 500 MG Oral CapsulePSN6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e4
309114cephalexin 500 MG Oral CapsuleSCD6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e4
309114cephalexin 500 MG Oral CapsulePSNb9055316-6bda-434c-9620-046cd4623db33
309114cephalexin 500 MG Oral CapsulePSN86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cephalexin 500 MG Oral CapsulePSNffead704-cd5f-489f-bf32-108a42b476063
309114cephalexin 500 MG Oral CapsuleSCD86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cephalexin 500 MG Oral CapsuleSCDb9055316-6bda-434c-9620-046cd4623db33
309114cephalexin 500 MG Oral CapsuleSCDffead704-cd5f-489f-bf32-108a42b476063
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb9055316-6bda-434c-9620-046cd4623db33
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYffead704-cd5f-489f-bf32-108a42b476063
309114cephalexin 500 MG Oral CapsulePSN8be6abb0-5ffa-499d-90d6-3c094cdf273e2
309114cephalexin 500 MG Oral CapsulePSN13444dc7-7da1-4181-a9ac-d95d4a235e6d2
309114cephalexin 500 MG Oral CapsulePSN278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cephalexin 500 MG Oral CapsulePSNb8136dc3-3942-4c72-a18c-00a6d823887d2
309114cephalexin 500 MG Oral CapsuleSCD8be6abb0-5ffa-499d-90d6-3c094cdf273e2
309114cephalexin 500 MG Oral CapsuleSCD278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cephalexin 500 MG Oral CapsuleSCDb8136dc3-3942-4c72-a18c-00a6d823887d2
309114cephalexin 500 MG Oral CapsuleSCD13444dc7-7da1-4181-a9ac-d95d4a235e6d2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb8136dc3-3942-4c72-a18c-00a6d823887d2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8be6abb0-5ffa-499d-90d6-3c094cdf273e2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY13444dc7-7da1-4181-a9ac-d95d4a235e6d2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY278c84f7-530c-45d5-bdcb-78a3cc1a37002
309112cephalexin 250 MG Oral CapsulePSN6032b68f-16d8-41b6-bd2c-86d5406a757a1
309114cephalexin 500 MG Oral CapsulePSN508a3401-df0b-0555-e063-6294a90a155a1
309114cephalexin 500 MG Oral CapsulePSN21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cephalexin 500 MG Oral CapsulePSN6032b68f-16d8-41b6-bd2c-86d5406a757a1
309112cephalexin 250 MG Oral CapsuleSCD6032b68f-16d8-41b6-bd2c-86d5406a757a1
309114cephalexin 500 MG Oral CapsuleSCD508a3401-df0b-0555-e063-6294a90a155a1
309114cephalexin 500 MG Oral CapsuleSCD6032b68f-16d8-41b6-bd2c-86d5406a757a1
309114cephalexin 500 MG Oral CapsuleSCD21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY508a3401-df0b-0555-e063-6294a90a155a1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6032b68f-16d8-41b6-bd2c-86d5406a757a1
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY6032b68f-16d8-41b6-bd2c-86d5406a757a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-122-0168180012201100 CAPSULE in 1 BOTTLE (68180-122-01) 100 capsule2006-11-010000-00-00NoNoCurrent
68180-122-0268180012202500 CAPSULE in 1 BOTTLE (68180-122-02) 500 capsule2006-11-010000-00-00NoNoCurrent