AMOXICILLIN

Product NDC
61919-366
11-digit product format
619190366
Labeler code
61919
Product ID
61919-366_bf7babad-0862-47a7-b8d5-b9ff780f10f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin tablet, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Direct RX
Application
ANDA065256
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-366-202020-01-31C16284748780-19d75b9d1-21de-f424-e053-dadaa90a57ceAMOXICILLIN - amoxicillin tablet, film coated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-366-20AMOXICILLIN20 in 1 BOTTLETABLET201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-366-20EA - Each61919-3663879da63-aa9b-4e2b-a2f3-69c0d49e2ca012016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-366AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1Legacy NDC, 1 package rows20150626_9179bb1b-8554-4c00-a323-aac951ae2f55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin 875 MG Oral TabletSCD9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9179bb1b-8554-4c00-a323-aac951ae2f551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-366-206191903662020 in 1 BOTTLEHistorical