FDA.reportPublic FDA data

Amoxicillin

Product NDC
57237-030
11-digit product format
572370030
Labeler code
57237
Product ID
57237-030_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
250 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
AMOXICILLIN250 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
57237-030-01Amoxicillin100 in 1 BOTTLECAPSULE1009
57237-030-05Amoxicillin500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-030-01EA - Each57237-03049fdf6d4-4bc0-4d77-b915-94591e755a6312014-04-03
57237-030-05EA - Each57237-030ba73c9de-579c-4601-9828-a793e8c7462112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
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
57237-030AMOXICILLIN 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 CapsulePSNd37f2e3c-01f0-4a81-a46f-1615b82e249923
308182amoxicillin 250 MG Oral CapsuleSCDd37f2e3c-01f0-4a81-a46f-1615b82e249923
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYd37f2e3c-01f0-4a81-a46f-1615b82e249923
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
308182amoxicillin 250 MG Oral CapsulePSN23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin 500 MG Oral CapsulePSN23979212-e989-4a8e-8dc8-46c5b4ecd59011
308182amoxicillin 250 MG Oral CapsuleSCD23979212-e989-4a8e-8dc8-46c5b4ecd59011
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
308182amoxicillin 250 MG Oral CapsulePSNbbe590a0-4196-4885-b679-cc1833af567f9
308191amoxicillin 500 MG Oral CapsulePSNbbe590a0-4196-4885-b679-cc1833af567f9
308182amoxicillin 250 MG Oral CapsuleSCDbbe590a0-4196-4885-b679-cc1833af567f9
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 CapsuleSYbbe590a0-4196-4885-b679-cc1833af567f9
308182amoxicillin 250 MG Oral CapsulePSN891602c6-54e6-a631-e053-2a95a90ab32b8
308182amoxicillin 250 MG Oral CapsuleSCD891602c6-54e6-a631-e053-2a95a90ab32b8
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY891602c6-54e6-a631-e053-2a95a90ab32b8
308182amoxicillin 250 MG Oral CapsulePSNd6a33b28-f520-4a4c-b553-0ebd005583455
308182amoxicillin 250 MG Oral CapsuleSCDd6a33b28-f520-4a4c-b553-0ebd005583455
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYd6a33b28-f520-4a4c-b553-0ebd005583455
308182amoxicillin 250 MG Oral CapsulePSN95fbd9d9-5255-2fd1-e053-2995a90a8b5c3
308182amoxicillin 250 MG Oral CapsulePSN75d7d780-de4b-72dd-e053-2991aa0a07663
308182amoxicillin 250 MG Oral CapsuleSCD95fbd9d9-5255-2fd1-e053-2995a90a8b5c3
308182amoxicillin 250 MG Oral CapsuleSCD75d7d780-de4b-72dd-e053-2991aa0a07663
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY95fbd9d9-5255-2fd1-e053-2995a90a8b5c3
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY75d7d780-de4b-72dd-e053-2991aa0a07663
308182amoxicillin 250 MG Oral CapsulePSNb7b3afb9-4572-118f-e053-2995a90ab60e2
308182amoxicillin 250 MG Oral CapsuleSCDb7b3afb9-4572-118f-e053-2995a90ab60e2
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYb7b3afb9-4572-118f-e053-2995a90ab60e2
308182amoxicillin 250 MG Oral CapsulePSNb83f36ea-4101-2883-e053-2995a90a644f1
308182amoxicillin 250 MG Oral CapsuleSCDb83f36ea-4101-2883-e053-2995a90a644f1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYb83f36ea-4101-2883-e053-2995a90a644f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-030-0157237003001100 CAPSULE in 1 BOTTLE (57237-030-01) 100 capsule2005-11-090000-00-00NoNoCurrent
57237-030-0557237003005500 CAPSULE in 1 BOTTLE (57237-030-05) 500 capsule2005-11-090000-00-00NoNoCurrent