FDA.reportPublic FDA data

Amoxicillin

Product NDC
71205-507
11-digit product format
712050507
Labeler code
71205
Product ID
71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui308191

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
71205-507-14Amoxicillin14 in 1 BOTTLECAPSULE143
71205-507-20Amoxicillin20 in 1 BOTTLECAPSULE203
71205-507-21Amoxicillin21 in 1 BOTTLECAPSULE213
71205-507-30Amoxicillin30 in 1 BOTTLECAPSULE303
71205-507-40Amoxicillin40 in 1 BOTTLECAPSULE403
71205-507-60Amoxicillin60 in 1 BOTTLECAPSULE603
71205-507-90Amoxicillin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-507-14EA - Each71205-5076ef86e82-0450-46bd-9ecb-8daaddb5606a12021-02-05
71205-507-20EA - Each71205-50733dadc2c-d2b7-44be-89f8-6ad8783abbd012024-02-14
71205-507-21EA - Each71205-507eeae587d-c6f5-4cba-a948-ea10fa45091612021-03-02
71205-507-30EA - Each71205-5079445a9ae-56d3-4f69-b44c-7bbaf1fdb75112021-03-02
71205-507-40EA - Each71205-507cf25a63f-ab5d-4bc1-96d8-134cf0550b3612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-507AMOXICILLIN CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20240123_66404ced-5ef4-4a31-9276-8c6f86add61c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN66404ced-5ef4-4a31-9276-8c6f86add61c3
308191amoxicillin 500 MG Oral CapsuleSCD66404ced-5ef4-4a31-9276-8c6f86add61c3
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY66404ced-5ef4-4a31-9276-8c6f86add61c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-507-147120505071414 CAPSULE in 1 BOTTLE (71205-507-14) 14 capsule2020-12-280000-00-00NoNoCurrent
71205-507-207120505072020 CAPSULE in 1 BOTTLE (71205-507-20) 20 capsule2022-05-02NoNoHistorical
71205-507-217120505072121 CAPSULE in 1 BOTTLE (71205-507-21) 21 capsule2020-12-280000-00-00NoNoCurrent
71205-507-307120505073030 CAPSULE in 1 BOTTLE (71205-507-30) 30 capsule2020-12-280000-00-00NoNoCurrent
71205-507-407120505074040 CAPSULE in 1 BOTTLE (71205-507-40) 40 capsule2020-12-280000-00-00NoNoCurrent
71205-507-607120505076060 CAPSULE in 1 BOTTLE (71205-507-60) 60 capsule2020-12-280000-00-00NoNoCurrent
71205-507-907120505079090 CAPSULE in 1 BOTTLE (71205-507-90) 90 capsule2020-12-280000-00-00NoNoCurrent