FDA.reportPublic FDA data

Amoxicillin

Product NDC
43063-820
11-digit product format
430630820
Labeler code
43063
Product ID
43063-820_415ba882-4d6f-3d31-e063-6394a90a3858
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-11-09
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
Rxcui308191

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
43063-820-04Amoxicillin4 in 1 BOTTLE, PLASTICCAPSULE435
43063-820-06Amoxicillin6 in 1 BOTTLE, PLASTICCAPSULE635
43063-820-08Amoxicillin8 in 1 BOTTLE, PLASTICCAPSULE835
43063-820-14Amoxicillin14 in 1 BOTTLE, PLASTICCAPSULE1435
43063-820-15Amoxicillin15 in 1 BOTTLE, PLASTICCAPSULE1535
43063-820-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE2035
43063-820-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE2135
43063-820-28Amoxicillin28 in 1 BOTTLE, PLASTICCAPSULE2835
43063-820-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE3035
43063-820-40Amoxicillin40 in 1 BOTTLE, PLASTICCAPSULE4035
43063-820-50Amoxicillin50 in 1 BOTTLE, PLASTICCAPSULE5035
43063-820-56Amoxicillin56 in 1 BOTTLE, PLASTICCAPSULE5635

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-820-04EA - Each43063-820dbc54f46-546c-4a23-81c7-47aea198e40612019-04-11
43063-820-06EA - Each43063-82052923a3d-c0fe-4d45-bbfd-d4512f9c199112018-04-19
43063-820-08EA - Each43063-820165e3077-0d03-4e36-809b-545f83a9743e12018-10-11
43063-820-14EA - Each43063-8202475c197-3021-4d7b-8dd3-a3e5bedd138412018-07-03
43063-820-15EA - Each43063-8207686a32a-7878-4933-b50f-4625bb91e1b712018-02-20
43063-820-20EA - Each43063-820e2dc7437-9d32-4abc-99f8-546e6ebb8ca512021-01-08
43063-820-21EA - Each43063-820194dad8d-8884-47fa-a8a5-5621eaadc37212018-03-08
43063-820-28EA - Each43063-82059cac5db-103a-446e-a359-3981d0eafc0d12018-04-19
43063-820-30EA - Each43063-820079a2d4b-5e02-4e28-91a6-49c02ce366a812018-05-09
43063-820-40EA - Each43063-820e4924d8e-54f7-4da8-8cb8-08777900f35412018-05-09
43063-820-50EA - Each43063-820420e36d2-59da-44e9-bac4-b8479e5e9b9312021-08-05
43063-820-56EA - Each43063-82025116603-f967-4bcd-9d0b-db70b851ab6312018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-820AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]34Current NDC, Legacy NDC, 12 package rows20240703_d0938df9-9065-47eb-9eae-0722ed1411a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNd0938df9-9065-47eb-9eae-0722ed1411a135
308191amoxicillin 500 MG Oral CapsuleSCDd0938df9-9065-47eb-9eae-0722ed1411a135
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYd0938df9-9065-47eb-9eae-0722ed1411a135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-820-04430630820044 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-04) 4 capsule2019-03-010000-00-00NoNoCurrent
43063-820-06430630820066 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-06) 6 capsule2018-03-090000-00-00NoNoCurrent
43063-820-08430630820088 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-08) 8 capsule2018-09-120000-00-00NoNoCurrent
43063-820-144306308201414 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-14) 14 capsule2018-05-180000-00-00NoNoCurrent
43063-820-154306308201515 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-15) 15 capsule2017-01-050000-00-00NoNoCurrent
43063-820-204306308202020 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-20) 20 capsule2020-12-020000-00-00NoNoCurrent
43063-820-214306308202121 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-21) 21 capsule2018-02-150000-00-00NoNoCurrent
43063-820-284306308202828 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-28) 28 capsule2018-02-260000-00-00NoNoCurrent
43063-820-304306308203030 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-30) 30 capsule2018-04-030000-00-00NoNoCurrent
43063-820-404306308204040 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-40) 40 capsule2018-04-030000-00-00NoNoCurrent
43063-820-504306308205050 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-50) 50 capsule2021-07-060000-00-00NoNoCurrent
43063-820-564306308205656 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-56) 56 capsule2018-02-260000-00-00NoNoCurrent