LACTULOSE

Product NDC: 0121-0577
11-digit product format: 001210577
Labeler code: 0121
Product ID: 0121-0577_ee162463-154d-b3e9-e053-2995a90a1528
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LACTULOSE
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc,
Application: ANDA074623
Marketing category: ANDA
Marketing start: 1966-07-30
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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	Strength	SPL version
0121-0577-16	LACTULOSE	473 mL in 1 BOTTLE	SOLUTION	473		22

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0577-08	ML - Milliliter	0121-0577	c7b0ae91-e2c4-4bf4-9e92-8094efc9b1d8	1	2013-02-13
0121-0577-16	ML - Milliliter	0121-0577	7ffd1b1a-1ef1-4430-b03d-5413d53071fa	1	2013-02-13
0121-0577-32	ML - Milliliter	0121-0577	494d154e-9dca-4ac8-8c74-31ea37312eec	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]	4
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,]	4
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]	1
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	LACTULOSE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]	1
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	LACTULOSE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
D&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LACTULOSE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTULOSE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTULOSE SOLUTION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTULOSE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0577	LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	21	Legacy NDC, 1 package rows	20241114_0f19e4ed-c90a-4330-a7fa-bf911aa98f09.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	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	22
391937	lactulose 667 MG/ML Oral Solution	SCD	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	22
391937	lactulose 10 GM per 15 ML Oral Solution	SY	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	22
391937	lactulose 20 GM per 30 ML Oral Solution	SY	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	22
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	a61e6ba8-b342-4815-9623-eb0c319ecc74	1
391937	lactulose 10 GM in 15 mL Oral Solution	PSN	ba296354-b01c-4b3f-a980-b8a0ac370932	1
391937	lactulose 667 MG/ML Oral Solution	SCD	a61e6ba8-b342-4815-9623-eb0c319ecc74	1
391937	lactulose 667 MG/ML Oral Solution	SCD	ba296354-b01c-4b3f-a980-b8a0ac370932	1
391937	lactulose 10 GM per 15 ML Oral Solution	SY	a61e6ba8-b342-4815-9623-eb0c319ecc74	1
391937	lactulose 10 GM per 15 ML Oral Solution	SY	ba296354-b01c-4b3f-a980-b8a0ac370932	1
391937	lactulose 20 GM per 30 ML Oral Solution	SY	a61e6ba8-b342-4815-9623-eb0c319ecc74	1
391937	lactulose 20 GM per 30 ML Oral Solution	SY	ba296354-b01c-4b3f-a980-b8a0ac370932	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0577-08	00121057708	237 mL in 1 BOTTLE (0121-0577-08)	237 ml	1966-07-30	0000-00-00	No	No	Current
0121-0577-16	00121057716	473 mL in 1 BOTTLE (0121-0577-16)	473 ml	1966-07-30	0000-00-00	No	No	Current
0121-0577-32	00121057732	946 mL in 1 BOTTLE (0121-0577-32)	946 ml	1966-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lactulose Solution USP 10 g/15 mL	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	22
Lactulose	Rebel Distributors Corp	2012-03-27	HUMAN PRESCRIPTION DRUG LABEL	1
Lactulose - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-12-31	HUMAN PRESCRIPTION DRUG LABEL	1