FDA.reportPublic FDA data

Cephalexin

Product NDC
43063-536
11-digit product format
430630536
Labeler code
43063
Product ID
43063-536_4d525d4b-43bb-9970-e063-6294a90a4e34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2011-01-19
Substance
CEPHALEXIN
Active strength
500 mg/1
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
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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
43063-536-04Cephalexin4 in 1 BOTTLE, PLASTICCAPSULE439
43063-536-06Cephalexin6 in 1 BOTTLE, PLASTICCAPSULE639
43063-536-08Cephalexin8 in 1 BOTTLE, PLASTICCAPSULE839
43063-536-09Cephalexin9 in 1 BOTTLE, PLASTICCAPSULE939
43063-536-10Cephalexin10 in 1 BOTTLE, PLASTICCAPSULE1039
43063-536-14Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE1439
43063-536-20Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE2039
43063-536-21Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE2139
43063-536-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2839
43063-536-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE3039
43063-536-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4039
43063-536-56Cephalexin56 in 1 BOTTLE, PLASTICCAPSULE5639

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-536-04EA - Each43063-536b3cb5b7b-1cd8-4e31-a1d8-e75756498c5012014-11-05
43063-536-06EA - Each43063-53673153452-64f9-4343-a24c-27dfc1fd3ba312014-11-05
43063-536-08EA - Each43063-536127b6c57-d01b-4e83-8fca-647344e8379f12015-03-03
43063-536-09EA - Each43063-536809d5dd6-4a80-4f0c-b99a-61f702cb85c912015-11-12
43063-536-10EA - Each43063-53682db5edb-d6c4-48f8-8d5a-bcc38cc4d20412015-01-05
43063-536-14EA - Each43063-536fec38e79-452c-491b-a6d9-7bd5b39af8bf12015-03-03
43063-536-20EA - Each43063-5369819cab5-cb5e-4ae0-aebd-1feaa243fedb12014-11-05
43063-536-21EA - Each43063-5364ceb523e-84e5-4f81-bdda-a2e36702935612014-11-05
43063-536-28EA - Each43063-53690f5f7cd-15bc-4ced-bdc3-ed3d0638aa2b12014-09-03
43063-536-30EA - Each43063-5365ae68c79-7c66-4876-a669-81be3bfe860912014-11-05
43063-536-40EA - Each43063-53673b99669-b33f-4185-bc77-cf25f76e36ff12014-11-05
43063-536-56EA - Each43063-536d3ec51c1-1066-4d78-8e72-0b6ad7bd6bd612014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
AMMONIAINACTIVE INGREDIENT5138Q19F1XCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-536CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]37Current NDC, Legacy NDC, 12 package rows20241013_a24a3c7c-c0f8-4107-ab30-751bea743d2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNa24a3c7c-c0f8-4107-ab30-751bea743d2d39
309114cephalexin 500 MG Oral CapsuleSCDa24a3c7c-c0f8-4107-ab30-751bea743d2d39
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYa24a3c7c-c0f8-4107-ab30-751bea743d2d39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-536-04430630536044 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-04) 4 capsule2014-02-060000-00-00NoNoCurrent
43063-536-06430630536066 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-06) 6 capsule2014-02-060000-00-00NoNoCurrent
43063-536-08430630536088 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-08) 8 capsule2014-02-060000-00-00NoNoCurrent
43063-536-09430630536099 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-09) 9 capsule2014-02-060000-00-00NoNoCurrent
43063-536-104306305361010 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-10) 10 capsule2014-02-060000-00-00NoNoCurrent
43063-536-144306305361414 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-14) 14 capsule2014-02-060000-00-00NoNoCurrent
43063-536-204306305362020 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-20) 20 capsule2014-02-060000-00-00NoNoCurrent
43063-536-214306305362121 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-21) 21 capsule2014-02-060000-00-00NoNoCurrent
43063-536-244306305362424 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-24) 24 capsule2014-02-060000-00-00NoNoCurrent
43063-536-284306305362828 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-28) 28 capsule2014-02-060000-00-00NoNoCurrent
43063-536-304306305363030 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-30) 30 capsule2014-02-060000-00-00NoNoCurrent
43063-536-404306305364040 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-40) 40 capsule2014-02-060000-00-00NoNoCurrent
43063-536-564306305365656 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-56) 56 capsule2014-02-060000-00-00NoNoCurrent