FDA.reportPublic FDA data

Cefdinir

Product NDC
0093-4136
11-digit product format
000934136
Labeler code
0093
Product ID
0093-4136_7f269e55-b085-4315-807a-e425f0189b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065332
Marketing category
ANDA
Marketing start
2007-05-08
Substance
CEFDINIR MONOHYDRATE
Active strength
125 mg/5mL
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
Cefdinir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR MONOHYDRATE125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E7SN358SE
Rxcui309054, 476576

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-4136-64Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION6015
0093-4136-73Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-4136CEFDINIR POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240305_a1f49fe1-b511-4f6b-a912-8ae8662d95a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNa1f49fe1-b511-4f6b-a912-8ae8662d95a515
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNa1f49fe1-b511-4f6b-a912-8ae8662d95a515
309054cefdinir 25 MG/ML Oral SuspensionSCDa1f49fe1-b511-4f6b-a912-8ae8662d95a515
476576cefdinir 50 MG/ML Oral SuspensionSCDa1f49fe1-b511-4f6b-a912-8ae8662d95a515
309054cefdinir 125 MG per 5 ML Oral SuspensionSYa1f49fe1-b511-4f6b-a912-8ae8662d95a515
476576cefdinir 250 MG per 5 ML Oral SuspensionSYa1f49fe1-b511-4f6b-a912-8ae8662d95a515
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN1d58b10c-b253-4925-8681-580aa2e8ae2e12
309054cefdinir 25 MG/ML Oral SuspensionSCD1d58b10c-b253-4925-8681-580aa2e8ae2e12
309054cefdinir 125 MG per 5 ML Oral SuspensionSY1d58b10c-b253-4925-8681-580aa2e8ae2e12
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 25 MG/ML Oral SuspensionSCD4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 125 MG per 5 ML Oral SuspensionSY4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNc335ee41-a4fe-43c9-bf21-91b24992378c3
309054cefdinir 25 MG/ML Oral SuspensionSCDc335ee41-a4fe-43c9-bf21-91b24992378c3
309054cefdinir 125 MG per 5 ML Oral SuspensionSYc335ee41-a4fe-43c9-bf21-91b24992378c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4136-640009341366460 mL in 1 BOTTLE (0093-4136-64) 60 ml2007-05-080000-00-00NoNoCurrent
0093-4136-7300093413673100 mL in 1 BOTTLE (0093-4136-73) 100 ml2007-05-080000-00-00NoNoCurrent