FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
62135-777
11-digit product format
621350777
Labeler code
62135
Product ID
62135-777_4690a5fd-79cc-e1fd-e063-6294a90a009c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA062059
Marketing category
ANDA
Marketing start
1978-12-08
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMOXICILLIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191, 313797

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
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-777-38AMOXICILLIN150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1502
62135-777-42AMOXICILLIN100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002
62135-777-68AMOXICILLIN80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-777-38ML - Milliliter62135-777c7a2c4d6-72d9-4ab8-b02f-8b1b356c7a5c12024-05-16
62135-777-42ML - Milliliter62135-7778ef2283c-7b25-4507-874d-c50175b2ec6612024-05-16
62135-777-68ML - Milliliter62135-7779b143d6b-a337-4723-a1ab-22200406f56312024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-777AMOXICILLIN POWDER, FOR SUSPENSION [CHARTWELL RX, LLC]1Current NDC, 3 package rows20240104_9ce26893-c7a1-47e9-98f9-f5d998cac418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN9ce26893-c7a1-47e9-98f9-f5d998cac4182
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN9ce26893-c7a1-47e9-98f9-f5d998cac4182
313797amoxicillin 25 MG/ML Oral SuspensionSCD9ce26893-c7a1-47e9-98f9-f5d998cac4182
239191amoxicillin 50 MG/ML Oral SuspensionSCD9ce26893-c7a1-47e9-98f9-f5d998cac4182
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY9ce26893-c7a1-47e9-98f9-f5d998cac4182
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY9ce26893-c7a1-47e9-98f9-f5d998cac4182
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY9ce26893-c7a1-47e9-98f9-f5d998cac4182
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY9ce26893-c7a1-47e9-98f9-f5d998cac4182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-777-3862135077738150 mL in 1 BOTTLE (62135-777-38) 150 ml2023-12-15NoNoHistorical
62135-777-4262135077742100 mL in 1 BOTTLE (62135-777-42) 100 ml2023-12-15NoNoHistorical
62135-777-686213507776880 mL in 1 BOTTLE (62135-777-68) 80 ml2023-12-15NoNoHistorical