FDA.reportPublic FDA data

Cephalexin

Product NDC
50090-4422
11-digit product format
500904422
Labeler code
50090
Product ID
50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
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
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
50090-4422-0Cephalexin20 in 1 BOTTLECAPSULE2020
50090-4422-1Cephalexin28 in 1 BOTTLECAPSULE2820
50090-4422-2Cephalexin40 in 1 BOTTLECAPSULE4020
50090-4422-3Cephalexin14 in 1 BOTTLECAPSULE1420
50090-4422-5Cephalexin10 in 1 BOTTLECAPSULE1020
50090-4422-6Cephalexin30 in 1 BOTTLECAPSULE3020
50090-4422-7Cephalexin100 in 1 BOTTLECAPSULE10020
50090-4422-8Cephalexin4 in 1 BOTTLECAPSULE420

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4422-0EA - Each50090-4422f65016b9-d4fb-4d9b-b179-6693ffaffecf12024-06-10
50090-4422-1EA - Each50090-4422534a794e-9463-4d8c-87df-ee98a8afbd3312024-06-10
50090-4422-2EA - Each50090-4422d147840c-77d6-4d50-8dba-b3990bb7fdc312024-06-10
50090-4422-3EA - Each50090-4422334e8342-05eb-4f0c-bee3-a1b2ff39a5be12024-06-10
50090-4422-5EA - Each50090-4422f50f476f-84d8-49b8-833c-de5e2f80b88212024-06-10
50090-4422-6EA - Each50090-44221af88dd0-1e3a-4487-b58c-4f0c86815c2312024-06-10
50090-4422-7EA - Each50090-4422c73d6150-f407-4091-8abd-196f484ba60c12024-06-10
50090-4422-8EA - Each50090-44226f807215-a25a-45c1-9960-0d6fc8882f8012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4422CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]20Current NDC, 8 package rows20240523_fc426d0d-9774-4189-8d83-89aa85d926bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNfc426d0d-9774-4189-8d83-89aa85d926bb20
309114cephalexin 500 MG Oral CapsuleSCDfc426d0d-9774-4189-8d83-89aa85d926bb20
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYfc426d0d-9774-4189-8d83-89aa85d926bb20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-4422-05009044220020 CAPSULE in 1 BOTTLE (50090-4422-0) 20 capsule2019-07-19NoNoCurrent
50090-4422-15009044220128 CAPSULE in 1 BOTTLE (50090-4422-1) 28 capsule2024-05-17NoNoCurrent
50090-4422-25009044220240 CAPSULE in 1 BOTTLE (50090-4422-2) 40 capsule2019-07-19NoNoCurrent
50090-4422-35009044220314 CAPSULE in 1 BOTTLE (50090-4422-3) 14 capsule2019-07-19NoNoCurrent
50090-4422-55009044220510 CAPSULE in 1 BOTTLE (50090-4422-5) 10 capsule2024-05-17NoNoCurrent
50090-4422-65009044220630 CAPSULE in 1 BOTTLE (50090-4422-6) 30 capsule2019-07-19NoNoCurrent
50090-4422-750090442207100 CAPSULE in 1 BOTTLE (50090-4422-7) 100 capsule2024-05-17NoNoCurrent
50090-4422-8500904422084 CAPSULE in 1 BOTTLE (50090-4422-8) 4 capsule2024-05-17NoNoCurrent