FDA.reportPublic FDA data

Amoxicillin

Product NDC
0093-4150
11-digit product format
000934150
Labeler code
0093
Product ID
0093-4150_9d940389-8043-4536-b668-847c281ff348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
2021-09-30
Substance
AMOXICILLIN
Active strength
125 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4150-73ML - Milliliter0093-4150a47cd0f3-9731-4d48-a1fb-9de1cd27040112012-07-24
0093-4150-79ML - Milliliter0093-4150d9a8b71e-c2f7-4af0-8af6-e8b98116e4a412012-07-24
0093-4150-80ML - Milliliter0093-415067bcf4ca-31c6-4943-893e-6415935676b012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN (AMOXICILLIN POWDER, FOR SUSPENSION) FOR SUSPENSION [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN63b395ca-f0ea-4429-b8aa-18f495596e4d29
598025amoxicillin 250 MG Chewable TabletPSN63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin 25 MG/ML Oral SuspensionSCD63b395ca-f0ea-4429-b8aa-18f495596e4d29
598025amoxicillin 250 MG Chewable TabletSCD63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin 50 MG/ML Oral SuspensionSCD63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN4ba96ba5-7e7c-4225-981f-593964c61a0c2
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN4ba96ba5-7e7c-4225-981f-593964c61a0c2
313797amoxicillin 25 MG/ML Oral SuspensionSCD4ba96ba5-7e7c-4225-981f-593964c61a0c2
239191amoxicillin 50 MG/ML Oral SuspensionSCD4ba96ba5-7e7c-4225-981f-593964c61a0c2
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY4ba96ba5-7e7c-4225-981f-593964c61a0c2
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY4ba96ba5-7e7c-4225-981f-593964c61a0c2
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY4ba96ba5-7e7c-4225-981f-593964c61a0c2
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY4ba96ba5-7e7c-4225-981f-593964c61a0c2
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSNe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSNb42baeeb-16b6-4a85-aa94-c405329259411
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin 25 MG/ML Oral SuspensionSCD8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin 25 MG/ML Oral SuspensionSCDe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
313797amoxicillin 25 MG/ML Oral SuspensionSCDb42baeeb-16b6-4a85-aa94-c405329259411
239191amoxicillin 50 MG/ML Oral SuspensionSCD8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin 50 MG/ML Oral SuspensionSCDe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSYb42baeeb-16b6-4a85-aa94-c405329259411
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSYe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
313797amoxicillin 125 MG per 5 ML Oral SuspensionSYb42baeeb-16b6-4a85-aa94-c405329259411
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin 125 MG per 5 ML Oral SuspensionSYe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYe82de7ec-0ca3-4afb-aa09-5ec5e7895b9d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4150-790009341507980 mL in 1 BOTTLE (0093-4150-79) 80 ml1990-09-302021-09-30NoNoCurrent