Amoxicillin

Product NDC
55289-019
11-digit product format
552890019
Labeler code
55289
Product ID
55289-019_f1fec2eb-752c-e8c8-e053-2995a90a340e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
55289-019-06EA - Each55289-019b18fe1e9-fdb3-4d8d-b625-43beca86285812012-07-24
55289-019-15EA - Each55289-019542d2c09-860d-4531-b29c-8bfb0a283adc12012-07-24
55289-019-21EA - Each55289-01941ddb8c9-a4a3-44b4-8b8f-45d7629c290e12012-07-24
55289-019-24EA - Each55289-0197ef119d0-4dd2-4e7a-a5c4-72450d85c57a12012-07-24
55289-019-30EA - Each55289-019b6edd9a4-a302-4cc6-899e-8b6b2c3d164a12012-07-24
55289-019-40EA - Each55289-01917ef7d6f-696d-44be-b7af-ef483d55104612012-07-24
55289-019-60EA - Each55289-0198a1e25e8-9eaf-4b9e-9310-59f67742fd3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-019AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]28Legacy NDC20250104_1d480bbc-9716-427e-a558-e6dd48a90edf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-019-06552890019066 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-06) 6 capsule2011-11-280000-00-00NoNoCurrent
55289-019-155528900191515 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-15) 15 capsule2011-11-280000-00-00NoNoCurrent
55289-019-215528900192121 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-21) 21 capsule2011-11-280000-00-00NoNoCurrent
55289-019-245528900192424 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-24) 24 capsule2011-11-280000-00-00NoNoCurrent
55289-019-305528900193030 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-30) 30 capsule2011-11-280000-00-00NoNoCurrent
55289-019-405528900194040 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-40) 40 capsule2011-11-280000-00-00NoNoCurrent
55289-019-605528900196060 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-60) 60 capsule2011-11-280000-00-00NoNoCurrent