FDA.reportPublic FDA data

Cephalexin

Product NDC
67877-220
11-digit product format
678770220
Labeler code
67877
Product ID
67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-20
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
IngredientStrength
CEPHALEXIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309112, 309114, 637173, 645617

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
67877-220-01Cephalexin100 in 1 BOTTLECAPSULE10028
67877-220-05Cephalexin500 in 1 BOTTLECAPSULE50028
67877-220-10Cephalexin1000 in 1 BOTTLECAPSULE100028
67877-220-20Cephalexin20 in 1 BOTTLECAPSULE2028
67877-220-38Cephalexin100 in 1 CARTONCAPSULE10028
67877-220-38Cephalexin1 in 1 BLISTER PACKCAPSULE128
67877-220-74Cephalexin50 in 1 CARTONCAPSULE5028
67877-220-74Cephalexin1 in 1 BLISTER PACKCAPSULE128
67877-220-84Cephalexin30 in 1 CARTONCAPSULE3028
67877-220-84Cephalexin1 in 1 BLISTER PACKCAPSULE128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-220-01EA - Each67877-22032b7bf7d-299e-4dcf-ad5e-7875aae5f80c12012-07-24
67877-220-05EA - Each67877-2204ba6b180-9b9f-4a60-9c0e-04506407926b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]20
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]18
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-220CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]28Current NDC, Legacy NDC, 10 package rows20220702_4fec8daf-6e09-4153-926f-64709dbdd26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN8a691ff2-eb16-4357-87ee-0ac9c99a5cb7106
309112cephalexin 250 MG Oral CapsulePSN2cb7bc3a-988b-4414-8036-fb09b2ab5767106
309112cephalexin 250 MG Oral CapsuleSCD8a691ff2-eb16-4357-87ee-0ac9c99a5cb7106
309112cephalexin 250 MG Oral CapsuleSCD2cb7bc3a-988b-4414-8036-fb09b2ab5767106
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY8a691ff2-eb16-4357-87ee-0ac9c99a5cb7106
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY2cb7bc3a-988b-4414-8036-fb09b2ab5767106
309112cephalexin 250 MG Oral CapsulePSN980b9dd9-cb61-4c4f-81ac-85ee5a7c2497105
309112cephalexin 250 MG Oral CapsuleSCD980b9dd9-cb61-4c4f-81ac-85ee5a7c2497105
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY980b9dd9-cb61-4c4f-81ac-85ee5a7c2497105
309112cephalexin 250 MG Oral CapsulePSN11efa03d-0da9-419a-b53d-65a5671dccb0104
309112cephalexin 250 MG Oral CapsulePSNcf1c5d03-eddc-463a-84ad-4d59362c2cf8104
309112cephalexin 250 MG Oral CapsuleSCDcf1c5d03-eddc-463a-84ad-4d59362c2cf8104
309112cephalexin 250 MG Oral CapsuleSCD11efa03d-0da9-419a-b53d-65a5671dccb0104
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYcf1c5d03-eddc-463a-84ad-4d59362c2cf8104
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY11efa03d-0da9-419a-b53d-65a5671dccb0104
309112cephalexin 250 MG Oral CapsulePSN8d25d863-9ec2-4b76-b2e5-d4e2e39639a5102
309112cephalexin 250 MG Oral CapsuleSCD8d25d863-9ec2-4b76-b2e5-d4e2e39639a5102
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY8d25d863-9ec2-4b76-b2e5-d4e2e39639a5102
309112cephalexin 250 MG Oral CapsulePSN0384c418-b4d4-4c06-9ed9-13e864b1980b100
309112cephalexin 250 MG Oral CapsuleSCD0384c418-b4d4-4c06-9ed9-13e864b1980b100
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY0384c418-b4d4-4c06-9ed9-13e864b1980b100
309112cephalexin 250 MG Oral CapsulePSNaf3e9919-3812-4917-bb6e-266a692ee4ab37
309112cephalexin 250 MG Oral CapsuleSCDaf3e9919-3812-4917-bb6e-266a692ee4ab37
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYaf3e9919-3812-4917-bb6e-266a692ee4ab37
309112cephalexin 250 MG Oral CapsulePSNe4e1ebcf-b43b-4dbe-9295-eeef67ba627232
309112cephalexin 250 MG Oral CapsulePSN1716ea1e-40a9-4a23-870b-3c7e3d07009532
309112cephalexin 250 MG Oral CapsuleSCDe4e1ebcf-b43b-4dbe-9295-eeef67ba627232
309112cephalexin 250 MG Oral CapsuleSCD1716ea1e-40a9-4a23-870b-3c7e3d07009532
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1716ea1e-40a9-4a23-870b-3c7e3d07009532
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYe4e1ebcf-b43b-4dbe-9295-eeef67ba627232
309112cephalexin 250 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
645617cephalexin 333 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
309114cephalexin 500 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
637173cephalexin 750 MG Oral CapsulePSN4fec8daf-6e09-4153-926f-64709dbdd26c28
309112cephalexin 250 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
645617cephalexin 333 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
309114cephalexin 500 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
637173cephalexin 750 MG Oral CapsuleSCD4fec8daf-6e09-4153-926f-64709dbdd26c28
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY4fec8daf-6e09-4153-926f-64709dbdd26c28
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY4fec8daf-6e09-4153-926f-64709dbdd26c28
309112cephalexin 250 MG Oral CapsulePSN73920373-b45d-45d6-b183-d962467dde3619
309112cephalexin 250 MG Oral CapsulePSN7cbdfa7f-2ea0-48e1-b506-59f58e5685a619
309114cephalexin 500 MG Oral CapsulePSN73920373-b45d-45d6-b183-d962467dde3619
309114cephalexin 500 MG Oral CapsulePSN7cbdfa7f-2ea0-48e1-b506-59f58e5685a619
309112cephalexin 250 MG Oral CapsuleSCD7cbdfa7f-2ea0-48e1-b506-59f58e5685a619
309112cephalexin 250 MG Oral CapsuleSCD73920373-b45d-45d6-b183-d962467dde3619
309114cephalexin 500 MG Oral CapsuleSCD7cbdfa7f-2ea0-48e1-b506-59f58e5685a619
309114cephalexin 500 MG Oral CapsuleSCD73920373-b45d-45d6-b183-d962467dde3619
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY73920373-b45d-45d6-b183-d962467dde3619
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY7cbdfa7f-2ea0-48e1-b506-59f58e5685a619
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY7cbdfa7f-2ea0-48e1-b506-59f58e5685a619
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY73920373-b45d-45d6-b183-d962467dde3619
309112cephalexin 250 MG Oral CapsulePSNa6b5edf2-1ef8-46b7-977a-8c303900f3f015
309112cephalexin 250 MG Oral CapsuleSCDa6b5edf2-1ef8-46b7-977a-8c303900f3f015
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYa6b5edf2-1ef8-46b7-977a-8c303900f3f015
309112cephalexin 250 MG Oral CapsulePSN6e5f9616-ddf2-19c4-e053-2991aa0a372a8
309112cephalexin 250 MG Oral CapsuleSCD6e5f9616-ddf2-19c4-e053-2991aa0a372a8
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY6e5f9616-ddf2-19c4-e053-2991aa0a372a8
309112cephalexin 250 MG Oral CapsulePSN6c543819-ab98-1dcd-e053-2991aa0a109d6
309112cephalexin 250 MG Oral CapsuleSCD6c543819-ab98-1dcd-e053-2991aa0a109d6
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY6c543819-ab98-1dcd-e053-2991aa0a109d6
309112cephalexin 250 MG Oral CapsulePSNc0e0533c-da78-7109-e053-2a95a90a4f5c4
309112cephalexin 250 MG Oral CapsulePSN7508351d-69fe-457c-b450-9a2343be25874
309112cephalexin 250 MG Oral CapsuleSCDc0e0533c-da78-7109-e053-2a95a90a4f5c4
309112cephalexin 250 MG Oral CapsuleSCD7508351d-69fe-457c-b450-9a2343be25874
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYc0e0533c-da78-7109-e053-2a95a90a4f5c4
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY7508351d-69fe-457c-b450-9a2343be25874
309112cephalexin 250 MG Oral CapsulePSN6e5f6627-b923-dbe2-e053-2a91aa0ade5c3
309112cephalexin 250 MG Oral CapsuleSCD6e5f6627-b923-dbe2-e053-2a91aa0ade5c3
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY6e5f6627-b923-dbe2-e053-2a91aa0ade5c3
309112cephalexin 250 MG Oral CapsulePSNc21ad1d9-bb3c-4756-8f38-aad902e8ab162
309112cephalexin 250 MG Oral CapsuleSCDc21ad1d9-bb3c-4756-8f38-aad902e8ab162
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYc21ad1d9-bb3c-4756-8f38-aad902e8ab162
309112cephalexin 250 MG Oral CapsulePSNbd5978cf-c83a-5804-e053-2995a90a111e1
309112cephalexin 250 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
309112cephalexin 250 MG Oral CapsulePSN35f8330a-ab31-13d3-e054-00144ff8d46c1
645617cephalexin 333 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
309114cephalexin 500 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
637173cephalexin 750 MG Oral CapsulePSN8073f183-e11f-41af-8bd1-1505bc7e044b1
309112cephalexin 250 MG Oral CapsuleSCDbd5978cf-c83a-5804-e053-2995a90a111e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-220-0167877022001100 CAPSULE in 1 BOTTLE (67877-220-01) 100 capsule2011-01-200000-00-00NoNoCurrent
67877-220-0567877022005500 CAPSULE in 1 BOTTLE (67877-220-05) 500 capsule2011-01-200000-00-00NoNoCurrent
67877-220-10678770220101000 CAPSULE in 1 BOTTLE (67877-220-10) 1000 capsule2011-01-200000-00-00NoNoCurrent
67877-220-206787702202020 CAPSULE in 1 BOTTLE (67877-220-20) 20 capsule2011-01-200000-00-00NoNoCurrent
67877-220-3867877022038100 BLISTER PACK in 1 CARTON (67877-220-38) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2011-01-200000-00-00NoNoCurrent
67877-220-746787702207450 BLISTER PACK in 1 CARTON (67877-220-74) / 1 CAPSULE in 1 BLISTER PACK50 blister pack2011-01-200000-00-00NoNoCurrent
67877-220-846787702208430 BLISTER PACK in 1 CARTON (67877-220-84) / 1 CAPSULE in 1 BLISTER PACK30 blister pack2011-01-200000-00-00NoNoCurrent