FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
70518-2225
11-digit product format
705182225
Labeler code
70518
Product ID
70518-2225_5218fbca-6f78-1231-e063-6294a90a8e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091568
Marketing category
ANDA
Marketing start
2019-07-19
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 125 mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562508

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
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2225-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2022
70518-2225-1Amoxicillin and Clavulanate Potassium30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-2225-2Amoxicillin and Clavulanate Potassium10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1022
70518-2225-3Amoxicillin and Clavulanate Potassium20 in 1 BLISTER PACKTABLET, FILM COATED2022
70518-2225-4Amoxicillin and Clavulanate Potassium14 in 1 BLISTER PACKTABLET, FILM COATED1422
70518-2225-5Amoxicillin and Clavulanate Potassium30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-2225-6Amoxicillin and Clavulanate Potassium100 in 1 BOXTABLET, FILM COATED10022
70518-2225-7Amoxicillin and Clavulanate Potassium1 in 1 POUCHTABLET, FILM COATED122
70518-2225-8Amoxicillin and Clavulanate Potassium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2225-0EA - Each70518-2225a5b9a53d-6c9a-404a-adf3-1b25ac3bb43e12025-12-16
70518-2225-1EA - Each70518-22252054b53c-5ce3-4f29-a3c7-6118e8c7220c12025-12-16
70518-2225-4EA - Each70518-222556162798-e4b0-46a2-8594-170b403ff11d12023-01-09
70518-2225-5EA - Each70518-2225c818ad45-0999-49a1-a1a1-36351623117b12023-01-09
70518-2225-6EA - Each70518-2225b61122d0-b36a-4cee-8ce4-b68fdb01593c12023-01-09
70518-2225-7EA - Each70518-2225125a7be7-e094-4474-b7dd-0e172c5bedb312023-01-09
70518-2225-8EA - Each70518-22255c5df3cd-8d9f-45c1-ba35-06c54911e39e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2225AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 9 package rows20250309_77b82fac-3f6e-44c9-8dcc-362f01ad7a4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN77b82fac-3f6e-44c9-8dcc-362f01ad7a4b22
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD77b82fac-3f6e-44c9-8dcc-362f01ad7a4b22
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY77b82fac-3f6e-44c9-8dcc-362f01ad7a4b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2225-07051822250020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-0) 2019-07-190000-00-00NoNoCurrent
70518-2225-17051822250130 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-1) 2020-06-100000-00-00NoNoCurrent
70518-2225-27051822250210 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-2) 2020-06-170000-00-00NoNoCurrent
70518-2225-37051822250320 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-3) 2020-08-310000-00-00NoNoCurrent
70518-2225-47051822250414 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-4) 2020-09-300000-00-00NoNoCurrent
70518-2225-57051822250530 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-5) 2021-04-060000-00-00NoNoCurrent
70518-2225-670518222506100 POUCH in 1 BOX (70518-2225-6) / 1 TABLET, FILM COATED in 1 POUCH (70518-2225-7) 100 pouch2021-10-110000-00-00NoNoCurrent
70518-2225-7705182225071 in 1 POUCHHistorical
70518-2225-87051822250814 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-8) 2021-12-070000-00-00NoNoCurrent