FDA.reportPublic FDA data

Amoxicillin

Product NDC
43063-563
11-digit product format
430630563
Labeler code
43063
Product ID
43063-563_dd7eccbe-ad04-e61d-e053-2995a90a068e
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
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-563-06EA - Each43063-56323822328-2019-4ae6-9373-b6acbf2c465912015-08-04
43063-563-08EA - Each43063-563d01aa20f-8e40-4cdc-8d0a-30fcfcd65eb712016-03-04
43063-563-09EA - Each43063-563b4230104-f0ee-4bda-8d5f-c7f42772dff612015-08-04
43063-563-14EA - Each43063-56347f226d7-d75a-4fe3-a09f-5fc88c07068612016-01-13
43063-563-15EA - Each43063-56324690412-9f33-43da-80b5-5dfa3dccbfc212015-05-05
43063-563-21EA - Each43063-56324410141-71a1-49a5-a61c-2d14cc6b743012015-04-03
43063-563-28EA - Each43063-56345be1991-2c4c-4c0e-b176-c26e2711dc1d12015-05-05
43063-563-30EA - Each43063-56363aed9c6-5576-43d8-848f-d8ae6d4d5ee312015-04-03
43063-563-40EA - Each43063-56393d92a48-6822-4a4e-bf34-108ba8d2d0e912015-04-03
43063-563-56EA - Each43063-563e61d4522-691f-43a1-8b30-c8fc11e936ad12016-03-04
43063-563-60EA - Each43063-563ec45e6e2-9f21-4b2a-a948-b7786861bb2412016-01-13
43063-563-63EA - Each43063-56339461ff2-b685-4c0e-aab6-37a482f35a9712016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-563AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]23Legacy NDC20240508_ef524ab0-00ae-4a1f-ba68-d425a6685935.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNb0523dc3-668f-466f-9421-2aae3b9b57513
308191amoxicillin 500 MG Oral CapsuleSCDb0523dc3-668f-466f-9421-2aae3b9b57513
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb0523dc3-668f-466f-9421-2aae3b9b57513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-563-06430630563066 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-06) 6 capsule2015-06-220000-00-00NoNoCurrent
43063-563-08430630563088 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-08) 8 capsule2016-02-170000-00-00NoNoCurrent
43063-563-09430630563099 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-09) 9 capsule2015-05-060000-00-00NoNoCurrent
43063-563-144306305631414 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-14) 14 capsule2015-10-190000-00-00NoNoCurrent
43063-563-154306305631515 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-15) 15 capsule2015-04-140000-00-00NoNoCurrent
43063-563-214306305632121 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-21) 21 capsule2015-03-110000-00-00NoNoCurrent
43063-563-284306305632828 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-28) 28 capsule2015-03-110000-00-00NoNoCurrent
43063-563-304306305633030 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-30) 30 capsule2015-03-090000-00-00NoNoCurrent
43063-563-404306305634040 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-40) 40 capsule2015-03-230000-00-00NoNoCurrent
43063-563-564306305635656 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-56) 56 capsule2016-01-210000-00-00NoNoCurrent
43063-563-604306305636060 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-60) 60 capsule2015-10-190000-00-00NoNoCurrent
43063-563-634306305636363 CAPSULE in 1 BOTTLE, PLASTIC (43063-563-63) 63 capsule2016-08-010000-00-00NoNoCurrent