Cefdinir

Product NDC
68788-8323
11-digit product format
687888323
Labeler code
68788
Product ID
68788-8323_cfe64312-8c09-4ea9-ac4d-2e4a017452d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065264
Marketing category
ANDA
Marketing start
2023-01-23
Substance
CEFDINIR
Active strength
300 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
Cefdinir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui200346

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8323-2Cefdinir20 in 1 BOTTLECAPSULE204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8323-2EA - Each68788-83239cd383b6-460f-489f-ba8d-d2c9ab46e44412023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8323CEFDINIR CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, 1 package rows20250221_8787ea15-bf90-4178-9b0f-08b075f1aa3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN8787ea15-bf90-4178-9b0f-08b075f1aa3d4
200346cefdinir 300 MG Oral CapsuleSCD8787ea15-bf90-4178-9b0f-08b075f1aa3d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8323-26878883230220 CAPSULE in 1 BOTTLE (68788-8323-2) 20 capsule2023-01-23NoNoHistorical