FDA.reportPublic FDA data

Amoxicillin

Product NDC
57237-031
11-digit product format
572370031
Labeler code
57237
Product ID
57237-031_4e6f21c7-0e2a-4361-9549-ab42efd08d5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, 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
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
57237-031-01Amoxicillin100 in 1 BOTTLECAPSULE1009
57237-031-05Amoxicillin500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-031-01EA - Each57237-031e38ef169-4fdc-4983-82aa-0428963592f312014-04-03
57237-031-05EA - Each57237-031f14a3f48-6f59-4a7f-8cb1-b093b88c6f7512014-04-03

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
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PROFICIENT RX LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PROFICIENT RX LP]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PROFICIENT RX LP]3
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-031AMOXICILLIN CAPSULE [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 2 package rows20240306_bbe590a0-4196-4885-b679-cc1833af567f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin 500 MG Oral CapsulePSN5edc5d32-43d5-4418-9832-40363a919edc17
308182amoxicillin 250 MG Oral CapsuleSCD5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin 500 MG Oral CapsuleSCD5edc5d32-43d5-4418-9832-40363a919edc17
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY5edc5d32-43d5-4418-9832-40363a919edc17
308191amoxicillin 500 MG Oral CapsulePSNe13cafe2-f226-4021-81d8-7bd1f98b558212
308191amoxicillin 500 MG Oral CapsuleSCDe13cafe2-f226-4021-81d8-7bd1f98b558212
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYe13cafe2-f226-4021-81d8-7bd1f98b558212
308182amoxicillin 250 MG Oral CapsulePSN23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin 500 MG Oral CapsulePSNafb4149a-0714-4a85-b9e8-2379a8e6a30211
308191amoxicillin 500 MG Oral CapsulePSN23979212-e989-4a8e-8dc8-46c5b4ecd59011
308182amoxicillin 250 MG Oral CapsuleSCD23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin 500 MG Oral CapsuleSCDafb4149a-0714-4a85-b9e8-2379a8e6a30211
308191amoxicillin 500 MG Oral CapsuleSCD23979212-e989-4a8e-8dc8-46c5b4ecd59011
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYafb4149a-0714-4a85-b9e8-2379a8e6a30211
308191amoxicillin 500 MG Oral CapsulePSNc9300368-330a-41bd-97ca-c90ea9159c6d10
308191amoxicillin 500 MG Oral CapsuleSCDc9300368-330a-41bd-97ca-c90ea9159c6d10
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYc9300368-330a-41bd-97ca-c90ea9159c6d10
308182amoxicillin 250 MG Oral CapsulePSNbbe590a0-4196-4885-b679-cc1833af567f9
308191amoxicillin 500 MG Oral CapsulePSNef03286b-4ba7-4952-9ab1-90cacf3005049
308191amoxicillin 500 MG Oral CapsulePSNbbe590a0-4196-4885-b679-cc1833af567f9
308182amoxicillin 250 MG Oral CapsuleSCDbbe590a0-4196-4885-b679-cc1833af567f9
308191amoxicillin 500 MG Oral CapsuleSCDef03286b-4ba7-4952-9ab1-90cacf3005049
308191amoxicillin 500 MG Oral CapsuleSCDbbe590a0-4196-4885-b679-cc1833af567f9
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYbbe590a0-4196-4885-b679-cc1833af567f9
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYef03286b-4ba7-4952-9ab1-90cacf3005049
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYbbe590a0-4196-4885-b679-cc1833af567f9
308191amoxicillin 500 MG Oral CapsulePSN3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c68
308191amoxicillin 500 MG Oral CapsuleSCD3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c68
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c68
308191amoxicillin 500 MG Oral CapsulePSN7ee6b6b6-ae5b-2e39-e053-2991aa0a23777
308191amoxicillin 500 MG Oral CapsuleSCD7ee6b6b6-ae5b-2e39-e053-2991aa0a23777
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY7ee6b6b6-ae5b-2e39-e053-2991aa0a23777
308191amoxicillin 500 MG Oral CapsulePSN8995ac88-a094-2d16-e053-2a95a90a9a266
308191amoxicillin 500 MG Oral CapsulePSN05e88717-2ce3-4b1a-88af-c3f61a2d8cd56
308191amoxicillin 500 MG Oral CapsuleSCD8995ac88-a094-2d16-e053-2a95a90a9a266
308191amoxicillin 500 MG Oral CapsuleSCD05e88717-2ce3-4b1a-88af-c3f61a2d8cd56
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY8995ac88-a094-2d16-e053-2a95a90a9a266
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY05e88717-2ce3-4b1a-88af-c3f61a2d8cd56
308191amoxicillin 500 MG Oral CapsulePSN800f5fac-f2af-358f-e053-2a91aa0ad6a65
308191amoxicillin 500 MG Oral CapsulePSN4eb83e73-9dba-07ae-e054-00144ff8d46c5
308191amoxicillin 500 MG Oral CapsuleSCD800f5fac-f2af-358f-e053-2a91aa0ad6a65
308191amoxicillin 500 MG Oral CapsuleSCD4eb83e73-9dba-07ae-e054-00144ff8d46c5
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY800f5fac-f2af-358f-e053-2a91aa0ad6a65
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4eb83e73-9dba-07ae-e054-00144ff8d46c5
308191amoxicillin 500 MG Oral CapsulePSNf049551b-4708-eb13-e053-2a95a90afd1f3
308191amoxicillin 500 MG Oral CapsuleSCDf049551b-4708-eb13-e053-2a95a90afd1f3
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf049551b-4708-eb13-e053-2a95a90afd1f3
308191amoxicillin 500 MG Oral CapsulePSN5020950a-b248-a463-e063-6294a90ae57f1
308191amoxicillin 500 MG Oral CapsuleSCD5020950a-b248-a463-e063-6294a90ae57f1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY5020950a-b248-a463-e063-6294a90ae57f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-031-0157237003101100 CAPSULE in 1 BOTTLE (57237-031-01) 100 capsule2005-11-090000-00-00NoNoCurrent
57237-031-0557237003105500 CAPSULE in 1 BOTTLE (57237-031-05) 500 capsule2005-11-090000-00-00NoNoCurrent