Amoxicillin

Product NDC: 57237-032
11-digit product format: 572370032
Labeler code: 57237
Product ID: 57237-032_62bfc65c-04fe-43b5-b659-d37067b280c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA065334
Marketing category: ANDA
Marketing start: 2006-12-28
Substance: AMOXICILLIN
Active strength: 200 mg/5mL
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#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	200 mg/5mL

Field, Values table
Field	Values
Unii	804826J2HU
Rxcui	308189, 313850

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57237-032-01	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	10
57237-032-50	Amoxicillin	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	10
57237-032-75	Amoxicillin	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	10

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-032-01	ML - Milliliter	57237-032	6fd32e86-eac2-4255-b968-eccf342f639a	1	2014-04-03
57237-032-50	ML - Milliliter	57237-032	7f54f5db-eeea-4596-aac2-0ce69ecf0328	1	2015-01-05
57237-032-75	ML - Milliliter	57237-032	c3f51f59-0f4d-4db4-a1dc-6a3836bf0c31	1	2014-04-03

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-032	AMOXICILLIN POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.]	10	Current NDC, Legacy NDC, 3 package rows	20240814_554239db-69fe-405a-910a-d9f9e3f8b6ed.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	554239db-69fe-405a-910a-d9f9e3f8b6ed	10
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	735c4c61-a718-4df7-be91-7bea604d9e37	1
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	735c4c61-a718-4df7-be91-7bea604d9e37	1
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	735c4c61-a718-4df7-be91-7bea604d9e37	1
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	735c4c61-a718-4df7-be91-7bea604d9e37	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-032-01	57237003201	100 mL in 1 BOTTLE (57237-032-01)	100 ml	2006-12-28	0000-00-00	No	No	Current
57237-032-50	57237003250	50 mL in 1 BOTTLE (57237-032-50)	50 ml	2006-12-28	0000-00-00	No	No	Current
57237-032-75	57237003275	75 mL in 1 BOTTLE (57237-032-75)	75 ml	2006-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-08-06	Human Prescription Drug Label	10
Amoxicillin	Aidarex Pharmaceuticals LLC	2017-05-25	HUMAN PRESCRIPTION DRUG LABEL	1