Amoxicillin

Product NDC
62135-825
11-digit product format
621350825
Labeler code
62135
Product ID
62135-825_4690ed91-8da8-2e62-e063-6294a90a0ab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA062058
Marketing category
ANDA
Marketing start
1978-08-03
Substance
AMOXICILLIN
Active strength
500 mg/1
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
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308182, 308191

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
62135-825-05Amoxicillin500 in 1 BOTTLECAPSULE5002
62135-825-60Amoxicillin60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-825-05EA - Each62135-82597191eec-60ee-4671-8e50-9f62c1be2a5112024-05-16
62135-825-60EA - Each62135-82559f6ee1e-8815-4138-8033-5b58919f5aa512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-825AMOXICILLIN CAPSULE [CHARTWELL RX, LLC]1Current NDC, 2 package rows20240404_5002cce4-0abc-4446-888c-47396549d4da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN5002cce4-0abc-4446-888c-47396549d4da2
308191amoxicillin 500 MG Oral CapsulePSN5002cce4-0abc-4446-888c-47396549d4da2
308182amoxicillin 250 MG Oral CapsuleSCD5002cce4-0abc-4446-888c-47396549d4da2
308191amoxicillin 500 MG Oral CapsuleSCD5002cce4-0abc-4446-888c-47396549d4da2
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY5002cce4-0abc-4446-888c-47396549d4da2
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY5002cce4-0abc-4446-888c-47396549d4da2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-825-0562135082505500 CAPSULE in 1 BOTTLE (62135-825-05) 500 capsule2024-03-28NoNoHistorical
62135-825-606213508256060 CAPSULE in 1 BOTTLE (62135-825-60) 60 capsule2024-03-28NoNoHistorical