FDA.reportPublic FDA data

Amoxicillin

Product NDC
16714-299
11-digit product format
167140299
Labeler code
16714
Product ID
16714-299_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
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
16714-299-01Amoxicillin30 in 1 BOTTLECAPSULE3013
16714-299-02Amoxicillin50 in 1 BOTTLECAPSULE5013
16714-299-03Amoxicillin100 in 1 BOTTLECAPSULE10013
16714-299-04Amoxicillin500 in 1 BOTTLECAPSULE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-299-02EA - Each16714-29946b3d736-2fe1-4c73-bcd9-94a375d5edcf12012-07-24
16714-299-03EA - Each16714-2994d1e8a6a-b477-4b1d-a94a-0572dff9135612012-07-24
16714-299-04EA - Each16714-29905ddd977-2656-4ba8-8033-50681292747212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [NORTHSTAR RX LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-299AMOXICILLIN CAPSULE [NORTHSTAR RX LLC]13Current NDC, Legacy NDC, 4 package rows20240305_843f6053-63d9-47d2-81f1-b6aa78a7c20c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN843f6053-63d9-47d2-81f1-b6aa78a7c20c13
308191amoxicillin 500 MG Oral CapsulePSN843f6053-63d9-47d2-81f1-b6aa78a7c20c13
308182amoxicillin 250 MG Oral CapsuleSCD843f6053-63d9-47d2-81f1-b6aa78a7c20c13
308191amoxicillin 500 MG Oral CapsuleSCD843f6053-63d9-47d2-81f1-b6aa78a7c20c13
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY843f6053-63d9-47d2-81f1-b6aa78a7c20c13
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY843f6053-63d9-47d2-81f1-b6aa78a7c20c13
308191amoxicillin 500 MG Oral CapsulePSN4d0f063a-d896-4757-8f22-9614e2ad71d412
308191amoxicillin 500 MG Oral CapsuleSCD4d0f063a-d896-4757-8f22-9614e2ad71d412
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4d0f063a-d896-4757-8f22-9614e2ad71d412
308191amoxicillin 500 MG Oral CapsulePSN322feb95-8bd4-440a-bda2-29ee19b112348
308191amoxicillin 500 MG Oral CapsuleSCD322feb95-8bd4-440a-bda2-29ee19b112348
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY322feb95-8bd4-440a-bda2-29ee19b112348
308191amoxicillin 500 MG Oral CapsulePSN071086f5-e4ed-b1d9-e063-6294a90ad3047
308191amoxicillin 500 MG Oral CapsulePSN26202694-cf20-4b08-90cc-70a3d30cbb0f7
308191amoxicillin 500 MG Oral CapsuleSCD26202694-cf20-4b08-90cc-70a3d30cbb0f7
308191amoxicillin 500 MG Oral CapsuleSCD071086f5-e4ed-b1d9-e063-6294a90ad3047
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY071086f5-e4ed-b1d9-e063-6294a90ad3047
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY26202694-cf20-4b08-90cc-70a3d30cbb0f7
308191amoxicillin 500 MG Oral CapsulePSN1f818d89-be59-b43d-e063-6394a90a12c34
308191amoxicillin 500 MG Oral CapsuleSCD1f818d89-be59-b43d-e063-6394a90a12c34
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY1f818d89-be59-b43d-e063-6394a90a12c34
308191amoxicillin 500 MG Oral CapsulePSN66404ced-5ef4-4a31-9276-8c6f86add61c3
308191amoxicillin 500 MG Oral CapsulePSN73219f24-6eac-4472-b2a7-cad36936c1853
308191amoxicillin 500 MG Oral CapsuleSCD66404ced-5ef4-4a31-9276-8c6f86add61c3
308191amoxicillin 500 MG Oral CapsuleSCD73219f24-6eac-4472-b2a7-cad36936c1853
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY66404ced-5ef4-4a31-9276-8c6f86add61c3
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY73219f24-6eac-4472-b2a7-cad36936c1853
308191amoxicillin 500 MG Oral CapsulePSNf4e99b4f-2cf4-ba35-e053-2a95a90ada5f2
308191amoxicillin 500 MG Oral CapsulePSN32b224c2-1354-4b58-b082-b93330e6962b2
308191amoxicillin 500 MG Oral CapsuleSCDf4e99b4f-2cf4-ba35-e053-2a95a90ada5f2
308191amoxicillin 500 MG Oral CapsuleSCD32b224c2-1354-4b58-b082-b93330e6962b2
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf4e99b4f-2cf4-ba35-e053-2a95a90ada5f2
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY32b224c2-1354-4b58-b082-b93330e6962b2
308191amoxicillin 500 MG Oral CapsulePSN116f655e-e32f-5030-e063-6394a90a64e51
308191amoxicillin 500 MG Oral CapsulePSNfe9e12de-9be9-4211-9a58-c7ecd9e838d51
308191amoxicillin 500 MG Oral CapsulePSN5b42ae30-96b2-4ceb-8b7c-468a6816305b1
308191amoxicillin 500 MG Oral CapsuleSCD116f655e-e32f-5030-e063-6394a90a64e51
308191amoxicillin 500 MG Oral CapsuleSCD5b42ae30-96b2-4ceb-8b7c-468a6816305b1
308191amoxicillin 500 MG Oral CapsuleSCDfe9e12de-9be9-4211-9a58-c7ecd9e838d51
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfe9e12de-9be9-4211-9a58-c7ecd9e838d51
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY5b42ae30-96b2-4ceb-8b7c-468a6816305b1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY116f655e-e32f-5030-e063-6394a90a64e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-299-011671402990130 CAPSULE in 1 BOTTLE (16714-299-01) 30 capsule2005-11-090000-00-00NoNoCurrent
16714-299-021671402990250 CAPSULE in 1 BOTTLE (16714-299-02) 50 capsule2005-11-090000-00-00NoNoCurrent
16714-299-0316714029903100 CAPSULE in 1 BOTTLE (16714-299-03) 100 capsule2005-11-090000-00-00NoNoCurrent
16714-299-0416714029904500 CAPSULE in 1 BOTTLE (16714-299-04) 500 capsule2005-11-090000-00-00NoNoCurrent