Lactulose

Product NDC: 62135-002
11-digit product format: 621350002
Labeler code: 62135
Product ID: 62135-002_49798265-6d70-8bc1-e063-6394a90a59d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA209517
Marketing category: ANDA
Marketing start: 2018-11-23
Substance: LACTULOSE
Active strength: 10 g/15mL
Pharmacologic classes: Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
LACTULOSE	10 g/15mL

Field, Values table
Field	Values
Unii	9U7D5QH5AE
Rxcui	391937

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
13620a32-e3b4-4aad-8280-283dce30ddff	Product name	1	20260105
27883b46-af31-44b0-b4ce-e6b4f6d825a7	Product name	4	20250812
c1a80c95-0e51-52a0-75fa-75808f51ded8	Product name	2	20150421

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62135-002-24	Lactulose	10 in 1 TRAY	SOLUTION	10	5
62135-002-24	Lactulose	2 in 1 BOX	SOLUTION	2	5
62135-002-37	Lactulose	237 mL in 1 PACKAGE	SOLUTION	237	5
62135-002-47	Lactulose	473 mL in 1 PACKAGE	SOLUTION	473	5
62135-002-51	Lactulose	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15	5
62135-002-78	Lactulose	3785 mL in 1 PACKAGE	SOLUTION	3785	5
62135-002-94	Lactulose	946 mL in 1 PACKAGE	SOLUTION	946	5

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-002-24	ML - Milliliter	62135-002	560f3735-d54b-411a-9b28-6160b65e46fc	1	2024-08-12
62135-002-37	ML - Milliliter	62135-002	44c4ae05-1932-4566-bd38-e687d436e872	1	2024-05-16
62135-002-47	ML - Milliliter	62135-002	17b4e762-ca3f-4547-b19b-8c7a384fc9a2	1	2024-05-16
62135-002-51	ML - Milliliter	62135-002	0c321820-1372-42b6-ba4d-e2e73ee4281e	1	2024-08-12
62135-002-94	ML - Milliliter	62135-002	6e3aaa54-cc1f-4105-9cb4-b046f25c07f3	1	2024-05-16

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-002	LACTULOSE SOLUTION [CHARTWELL RX, LLC]	3	Current NDC, 7 package rows	20240601_d6975cd8-80e0-43e2-809a-175ea7e40715.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9U7D5QH5AE	LACTULOSE	4618-18-2	LACTULOSE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	d6975cd8-80e0-43e2-809a-175ea7e40715	5
391937	lactulose 667 MG/ML Oral Solution	SCD	d6975cd8-80e0-43e2-809a-175ea7e40715	5
391937	lactulose 10 GM per 15 ML Oral Solution	SY	d6975cd8-80e0-43e2-809a-175ea7e40715	5
391937	lactulose 20 GM per 30 ML Oral Solution	SY	d6975cd8-80e0-43e2-809a-175ea7e40715	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-002-24	62135000224	2 TRAY in 1 BOX (62135-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (62135-002-51)	2 tray	2024-03-19	No	No	Historical
62135-002-37	62135000237	237 mL in 1 PACKAGE (62135-002-37)	237 ml	2024-03-19	No	No	Historical
62135-002-47	62135000247	473 mL in 1 PACKAGE (62135-002-47)	473 ml	2024-03-19	No	No	Historical
62135-002-51	62135000251	15 mL in 1 CUP, UNIT-DOSE	15 ml				Historical
62135-002-78	62135000278	3785 mL in 1 PACKAGE (62135-002-78)	3785 ml	2024-03-19	No	No	Historical
62135-002-94	62135000294	946 mL in 1 PACKAGE (62135-002-94)	946 ml	2024-03-19	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lactulose Solution, USP For Oral Administration Rx ONLY	Chartwell RX, LLC	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	5