FDA.reportPublic FDA data

Amoxicillin

Product NDC
57237-029
11-digit product format
572370029
Labeler code
57237
Product ID
57237-029_679691e2-bbbf-4ed0-a31b-e538b3df75c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 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
AMOXICILLIN875 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308192, 308194

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-029-01Amoxicillin100 in 1 BOTTLETABLET, FILM COATED10010
57237-029-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-029-01EA - Each57237-029a6d1d761-e0ec-4237-9313-4dfa6a6b6d5912014-04-03
57237-029-20EA - Each57237-029a8882450-824b-43f5-89c9-f98efa20b50512015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-029AMOXICILLIN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20240809_bb7733f8-6aad-4273-84a0-ef472630203f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNb91f40dd-40db-473d-a399-166aeb1ce7e222
308194amoxicillin 875 MG Oral TabletPSNb91f40dd-40db-473d-a399-166aeb1ce7e222
308192amoxicillin 500 MG Oral TabletSCDb91f40dd-40db-473d-a399-166aeb1ce7e222
308194amoxicillin 875 MG Oral TabletSCDb91f40dd-40db-473d-a399-166aeb1ce7e222
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYb91f40dd-40db-473d-a399-166aeb1ce7e222
308194amoxicillin 875 MG Oral TabletPSNaaf42367-153e-4525-af5f-f5f1c7d6c55911
308194amoxicillin 875 MG Oral TabletSCDaaf42367-153e-4525-af5f-f5f1c7d6c55911
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYaaf42367-153e-4525-af5f-f5f1c7d6c55911
308192amoxicillin 500 MG Oral TabletPSNbb7733f8-6aad-4273-84a0-ef472630203f10
308194amoxicillin 875 MG Oral TabletPSNbb7733f8-6aad-4273-84a0-ef472630203f10
308192amoxicillin 500 MG Oral TabletSCDbb7733f8-6aad-4273-84a0-ef472630203f10
308194amoxicillin 875 MG Oral TabletSCDbb7733f8-6aad-4273-84a0-ef472630203f10
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYbb7733f8-6aad-4273-84a0-ef472630203f10
308194amoxicillin 875 MG Oral TabletPSNa2c91cf0-a4e4-44c0-b712-bee63dd6c22b7
308194amoxicillin 875 MG Oral TabletPSN4b23e6f5-9287-4c01-b795-b8c5388330397
308194amoxicillin 875 MG Oral TabletSCD4b23e6f5-9287-4c01-b795-b8c5388330397
308194amoxicillin 875 MG Oral TabletSCDa2c91cf0-a4e4-44c0-b712-bee63dd6c22b7
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY4b23e6f5-9287-4c01-b795-b8c5388330397
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYa2c91cf0-a4e4-44c0-b712-bee63dd6c22b7
308194amoxicillin 875 MG Oral TabletPSN313ea909-5b1b-41ff-a0db-5aadc12e2e4f6
308194amoxicillin 875 MG Oral TabletPSN15906fc2-67ce-4c7e-abc9-73bd1d9f54986
308194amoxicillin 875 MG Oral TabletPSN963986fc-0e59-21b0-e053-2a95a90a95316
308194amoxicillin 875 MG Oral TabletSCD313ea909-5b1b-41ff-a0db-5aadc12e2e4f6
308194amoxicillin 875 MG Oral TabletSCD15906fc2-67ce-4c7e-abc9-73bd1d9f54986
308194amoxicillin 875 MG Oral TabletSCD963986fc-0e59-21b0-e053-2a95a90a95316
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY15906fc2-67ce-4c7e-abc9-73bd1d9f54986
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY963986fc-0e59-21b0-e053-2a95a90a95316
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY313ea909-5b1b-41ff-a0db-5aadc12e2e4f6
308194amoxicillin 875 MG Oral TabletPSN8e6f9df1-0754-69e4-e053-2a95a90acc495
308194amoxicillin 875 MG Oral TabletSCD8e6f9df1-0754-69e4-e053-2a95a90acc495
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY8e6f9df1-0754-69e4-e053-2a95a90acc495
308194amoxicillin 875 MG Oral TabletPSN7c34c955-aa27-486b-bd23-13e6fbce7a6c3
308194amoxicillin 875 MG Oral TabletPSN4ea4ab20-93f6-57c2-e054-00144ff88e883
308194amoxicillin 875 MG Oral TabletSCD7c34c955-aa27-486b-bd23-13e6fbce7a6c3
308194amoxicillin 875 MG Oral TabletSCD4ea4ab20-93f6-57c2-e054-00144ff88e883
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY7c34c955-aa27-486b-bd23-13e6fbce7a6c3
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY4ea4ab20-93f6-57c2-e054-00144ff88e883
308192amoxicillin 500 MG Oral TabletPSNa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin 875 MG Oral TabletPSNa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin 875 MG Oral TabletPSN429a7c98-cb01-4059-e054-00144ff88e882
308194amoxicillin 875 MG Oral TabletPSN2183bef9-f79d-54f7-e054-00144ff88e882
308192amoxicillin 500 MG Oral TabletSCDa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin 875 MG Oral TabletSCDa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin 875 MG Oral TabletSCD429a7c98-cb01-4059-e054-00144ff88e882
308194amoxicillin 875 MG Oral TabletSCD2183bef9-f79d-54f7-e054-00144ff88e882
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY429a7c98-cb01-4059-e054-00144ff88e882
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY2183bef9-f79d-54f7-e054-00144ff88e882
308194amoxicillin 875 MG Oral TabletPSNa24a05ea-324d-4b2b-be71-6107e2b57fb41
308194amoxicillin 875 MG Oral TabletPSNbef50f2a-78c6-4d0c-8ad9-cfa3c801629d1
308194amoxicillin 875 MG Oral TabletSCDa24a05ea-324d-4b2b-be71-6107e2b57fb41
308194amoxicillin 875 MG Oral TabletSCDbef50f2a-78c6-4d0c-8ad9-cfa3c801629d1
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYa24a05ea-324d-4b2b-be71-6107e2b57fb41
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYbef50f2a-78c6-4d0c-8ad9-cfa3c801629d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-029-0157237002901100 TABLET, FILM COATED in 1 BOTTLE (57237-029-01) 2005-11-090000-00-00NoNoCurrent
57237-029-205723700292020 TABLET, FILM COATED in 1 BOTTLE (57237-029-20) 2005-11-090000-00-00NoNoCurrent