FDA.reportPublic FDA data

Cephalexin

Product NDC
43063-497
11-digit product format
430630497
Labeler code
43063
Product ID
43063-497_4138c4a5-e7dc-1683-e063-6394a90a05c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

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
43063-497-04Cephalexin4 in 1 BOTTLE, PLASTICCAPSULE437
43063-497-06Cephalexin6 in 1 BOTTLE, PLASTICCAPSULE637
43063-497-08Cephalexin8 in 1 BOTTLE, PLASTICCAPSULE837
43063-497-09Cephalexin9 in 1 BOTTLE, PLASTICCAPSULE937
43063-497-10Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE1037
43063-497-15Cephalexin15 in 1 BOTTLE, PLASTICCAPSULE1537
43063-497-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE2037
43063-497-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2837
43063-497-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE3037
43063-497-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-497-04EA - Each43063-497e6c20975-bccc-440e-b792-9f8bf2a02e6912014-05-02
43063-497-06EA - Each43063-497a3f98da5-72a2-43a2-bff5-86ff484ccfa112014-05-02
43063-497-08EA - Each43063-497ae43b2fb-6518-4cb7-b7b5-9086f4c0ff9412014-09-03
43063-497-09EA - Each43063-4972ee29945-51a5-4ae8-bdad-51e6b13b9a4d12014-09-03
43063-497-10EA - Each43063-497cdd3dbed-59cc-403d-b5ed-f6165b018fd112014-11-05
43063-497-15EA - Each43063-4971260fcd2-f2dd-4611-a2ea-779825d809a212014-05-02
43063-497-20EA - Each43063-4972d6ff80c-82b6-45b0-969e-5b008721024b12014-09-03
43063-497-28EA - Each43063-4976e11fee3-b0c6-4f7b-a52b-56c6cbe9e68612014-08-01
43063-497-30EA - Each43063-497530ea360-b10c-424c-ad3e-47c7674c6b6012014-05-02
43063-497-40EA - Each43063-497f5f885d6-c1f7-4e33-a3b0-09661f9ab36a12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-497CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]36Current NDC, Legacy NDC, 10 package rows20240720_af3e9919-3812-4917-bb6e-266a692ee4ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-497-04430630497044 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-04) 4 capsule2013-02-040000-00-00NoNoCurrent
43063-497-06430630497066 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-06) 6 capsule2013-02-040000-00-00NoNoCurrent
43063-497-08430630497088 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-08) 8 capsule2013-02-040000-00-00NoNoCurrent
43063-497-09430630497099 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-09) 9 capsule2013-02-040000-00-00NoNoCurrent
43063-497-104306304971010 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-10) 10 capsule2013-02-040000-00-00NoNoCurrent
43063-497-154306304971515 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-15) 15 capsule2013-02-040000-00-00NoNoCurrent
43063-497-204306304972020 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-20) 20 capsule2013-02-040000-00-00NoNoCurrent
43063-497-284306304972828 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-28) 28 capsule2013-02-040000-00-00NoNoCurrent
43063-497-304306304973030 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-30) 30 capsule2013-02-040000-00-00NoNoCurrent
43063-497-404306304974040 CAPSULE in 1 BOTTLE, PLASTIC (43063-497-40) 40 capsule2013-02-040000-00-00NoNoCurrent