Amoxicillin

Product NDC
55289-020
11-digit product format
552890020
Labeler code
55289
Product ID
55289-020_e6e997ff-d352-79a0-e053-2a95a90a1ba7
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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-020-04EA - Each55289-020e43ad63e-5965-4496-bf92-88d738abd64112012-07-24
55289-020-06EA - Each55289-020951f2b6b-0f72-4479-8a8c-b88c14fa6b4812012-07-24
55289-020-09EA - Each55289-0204885c899-6ee3-4aa3-a54f-fddd62297c4c12012-07-24
55289-020-14EA - Each55289-0201c053078-f89e-4cb7-b02e-63019aa6d19012012-07-24
55289-020-15EA - Each55289-020c73f6a18-3aca-46e6-b59d-3fe46c49818b12012-07-24
55289-020-21EA - Each55289-0200d93c225-e8cc-42b0-b193-3481441f3af512012-07-24
55289-020-24EA - Each55289-02046a283e0-3b4d-4a9d-81d8-5b8ff88f5a2512012-07-24
55289-020-28EA - Each55289-02093fbc4c7-944c-40b4-a32e-8665def0558112012-07-24
55289-020-30EA - Each55289-02022b380f5-a28c-493f-8bdb-7c5c8cdc18c712012-07-24
55289-020-40EA - Each55289-0200a416e16-1609-416c-9138-b1dff044fb2312012-07-24
55289-020-42EA - Each55289-0204f414cac-b3f2-4b2a-ae25-0957b64b5fdd12013-04-01
55289-020-50EA - Each55289-0208f4687b8-e2e7-4ff3-9eb0-1bfdd8d515eb12012-07-24
55289-020-56EA - Each55289-0202a0c8279-e586-49b6-bc77-7c7b82ffc16012012-07-24
55289-020-60EA - Each55289-0205c737d47-2804-4eef-860a-68d6e50ee6e112012-07-24
55289-020-63EA - Each55289-0209d0fed61-e08e-4105-a09d-28d3cdcc6dd012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-020AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]29Legacy NDC20250104_610ead3d-a415-4762-8c3c-91c87665f138.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-020-04552890020044 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-04) 4 capsule2013-03-250000-00-00NoNoCurrent
55289-020-06552890020066 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-06) 6 capsule2013-03-250000-00-00NoNoCurrent
55289-020-09552890020099 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-09) 9 capsule2013-03-250000-00-00NoNoCurrent
55289-020-145528900201414 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-14) 14 capsule2013-03-250000-00-00NoNoCurrent
55289-020-155528900201515 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-15) 15 capsule2013-03-250000-00-00NoNoCurrent
55289-020-215528900202121 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-21) 21 capsule2013-03-250000-00-00NoNoCurrent
55289-020-245528900202424 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-24) 24 capsule2013-03-250000-00-00NoNoCurrent
55289-020-285528900202828 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-28) 28 capsule2013-03-250000-00-00NoNoCurrent
55289-020-305528900203030 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-30) 30 capsule2013-03-250000-00-00NoNoCurrent
55289-020-405528900204040 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-40) 40 capsule2013-03-250000-00-00NoNoCurrent
55289-020-425528900204242 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-42) 42 capsule2013-03-250000-00-00NoNoCurrent
55289-020-505528900205050 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-50) 50 capsule2013-03-250000-00-00NoNoCurrent
55289-020-565528900205656 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-56) 56 capsule2013-03-250000-00-00NoNoCurrent
55289-020-605528900206060 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-60) 60 capsule2013-03-250000-00-00NoNoCurrent
55289-020-635528900206363 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-63) 63 capsule2013-03-250000-00-00NoNoCurrent