FDA.reportPublic FDA data

Amoxicillin

Product NDC
65862-016
11-digit product format
658620016
Labeler code
65862
Product ID
65862-016_4dc94f3c-990d-476f-a88e-df9967570eec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
65862-016-01Amoxicillin100 in 1 BOTTLECAPSULE10020
65862-016-05Amoxicillin500 in 1 BOTTLECAPSULE50020
65862-016-20Amoxicillin20 in 1 BOTTLECAPSULE2020
65862-016-30Amoxicillin30 in 1 BOTTLECAPSULE3020
65862-016-50Amoxicillin50 in 1 BOTTLECAPSULE5020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-016-01EA - Each65862-016a3852356-d164-4277-96b2-73a7e54c718612012-07-24
65862-016-05EA - Each65862-0160f36be81-af4b-4f37-915a-941fdbe359f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [STAT RX USA LLC]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [STAT RX USA LLC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [STAT RX USA LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [STAT RX USA LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [STAT RX USA LLC]2
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [STAT RX USA LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [STAT RX USA LLC]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [APOTHECA INC.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN CAPSULE [APOTHECA INC.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [APOTHECA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [APOTHECA INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [APOTHECA INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [APOTHECA INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [APOTHECA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [APOTHECA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [APOTHECA INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [APOTHECA INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-016AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 5 package rows20240203_7e3a4517-1934-4e03-b96b-4ad65ab076c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN7e3a4517-1934-4e03-b96b-4ad65ab076c520
308191amoxicillin 500 MG Oral CapsulePSN7e3a4517-1934-4e03-b96b-4ad65ab076c520
308182amoxicillin 250 MG Oral CapsuleSCD7e3a4517-1934-4e03-b96b-4ad65ab076c520
308191amoxicillin 500 MG Oral CapsuleSCD7e3a4517-1934-4e03-b96b-4ad65ab076c520
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY7e3a4517-1934-4e03-b96b-4ad65ab076c520
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY7e3a4517-1934-4e03-b96b-4ad65ab076c520
308182amoxicillin 250 MG Oral CapsulePSN8f8b1fe6-23cb-2105-e053-2a95a90aeede5
308182amoxicillin 250 MG Oral CapsuleSCD8f8b1fe6-23cb-2105-e053-2a95a90aeede5
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY8f8b1fe6-23cb-2105-e053-2a95a90aeede5
308182amoxicillin 250 MG Oral CapsulePSNf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin 500 MG Oral CapsulePSNf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin 250 MG Oral CapsuleSCDf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin 500 MG Oral CapsuleSCDf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin 250 MG Oral CapsulePSN78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsulePSNfc61c9f5-b0f8-3ff8-e053-6394a90adeb72
308191amoxicillin 500 MG Oral CapsulePSN78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsuleSCD78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsuleSCDfc61c9f5-b0f8-3ff8-e053-6394a90adeb72
308191amoxicillin 500 MG Oral CapsuleSCD78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYfc61c9f5-b0f8-3ff8-e053-6394a90adeb72
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY78cabf7c-f342-4285-bc5a-9f24789d44ed2
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsulePSN1c755ad7-f0a8-4a63-a686-413bae57f8d01
308182amoxicillin 250 MG Oral CapsulePSN9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin 250 MG Oral CapsulePSNa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin 250 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsulePSN9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308191amoxicillin 500 MG Oral CapsulePSNa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin 500 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin 250 MG Oral CapsuleSCD9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin 250 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin 250 MG Oral CapsuleSCDa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin 250 MG Oral CapsuleSCD1c755ad7-f0a8-4a63-a686-413bae57f8d01
308191amoxicillin 500 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsuleSCDa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin 500 MG Oral CapsuleSCD9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY1c755ad7-f0a8-4a63-a686-413bae57f8d01
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-016-0165862001601100 CAPSULE in 1 BOTTLE (65862-016-01) 100 capsule2005-11-090000-00-00NoNoCurrent
65862-016-0565862001605500 CAPSULE in 1 BOTTLE (65862-016-05) 500 capsule2005-11-090000-00-00NoNoCurrent
65862-016-18658620016181800 CAPSULE in 1 BAG (65862-016-18)1800 capsule11-SEP-05Current
65862-016-206586200162020 CAPSULE in 1 BOTTLE (65862-016-20) 20 capsule2005-11-090000-00-00NoNoCurrent
65862-016-22658620016222000 CAPSULE in 1 BAG (65862-016-22)2000 capsule11-SEP-05Current
65862-016-306586200163030 CAPSULE in 1 BOTTLE (65862-016-30) 30 capsule2005-11-090000-00-00NoNoCurrent
65862-016-506586200165050 CAPSULE in 1 BOTTLE (65862-016-50) 50 capsule2005-11-090000-00-00NoNoCurrent