LACTULOSE

Product NDC: 0121-4577
11-digit product format: 001214577
Labeler code: 0121
Product ID: 0121-4577_6843c997-c52c-4978-b087-647f7c3fa782
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LACTULOSE
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA074623
Marketing category: ANDA
Marketing start: 1966-07-30
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0121-4577	0121-4577-06	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-4577	0121-4577-06	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074623-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074623-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1996-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074623-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		1996-07-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074623-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074623-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074623-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074623-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074623-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074623-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074623-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074623-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074623-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074623-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074623-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074623-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074623-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074623-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074623-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074623-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074623-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074623-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074623-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074623-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074623-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074623-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074623-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074623-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074623-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074623-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074623-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074623-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074623-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074623-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074623-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074623-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074623-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074623-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074623-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074623-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074623-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074623-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074623-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074623-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: LACTULOSE
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9U7D5QH5AE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
391937	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0f19e4ed-c90a-4330-a7fa-bf911aa98f09	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-4577-06	LACTULOSE	6 in 1 CASE	SOLUTION	6	22
0121-4577-06	LACTULOSE	16 in 1 CARTON	SOLUTION	16	22
0121-4577-15	LACTULOSE	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15	22
0121-4577-40	LACTULOSE	4 in 1 CASE	SOLUTION	4	22
0121-4577-40	LACTULOSE	10 in 1 TRAY	SOLUTION	10	22
0121-4577-50	LACTULOSE	5 in 1 TRAY	SOLUTION	5	22
0121-4577-50	LACTULOSE	5 in 1 CASE	SOLUTION	5	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-4577-06	ML - Milliliter	0121-4577	672adaf2-245b-428a-9f01-4b0a64135093	1	2020-01-03
0121-4577-15	ML - Milliliter	0121-4577	eba61e72-972b-4697-8cc9-a153ee50ab59	1	2013-02-13
0121-4577-30	ML - Milliliter	0121-4577	f2e1c85d-d351-405b-8d5b-ecbbfe6d3769	1	2013-02-13
0121-4577-35	ML - Milliliter	0121-4577	c5da7441-ee43-4089-ba07-b41abc8ef491	1	2014-09-03
0121-4577-40	ML - Milliliter	0121-4577	6966f60d-98ff-4174-8c16-95b21dea688f	1	2017-03-06

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-4577	LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	21	Current NDC, Legacy NDC, 7 package rows	20241114_0f19e4ed-c90a-4330-a7fa-bf911aa98f09.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACTULOSE	LACTULOSE	Cardinal Health 107, LLC	3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623
LACTULOSE	LACTULOSE	Atlantic Biologicals Corp.	3fb6e908-893c-5a57-e063-6294a90a1bfc	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623
LACTULOSE	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	0f19e4ed-c90a-4330-a7fa-bf911aa98f09	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623 ndc (product): 0121-4577
LACTULOSE	LACTULOSE	PAI Holdings, LLC dba PAI Pharma	cbf0497c-9c8d-4dfa-bebd-64c589468401	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623
LACTULOSE	LACTULOSE	Proficient Rx LP	6bbabdc6-f6a8-4f67-a448-e452d1928deb	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074623 application number: ANDA074623

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

DailyMed RxNorm Mappings#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-4577-06	00121457706	6 CARTON in 1 CASE (0121-4577-06) > 16 CUP, UNIT-DOSE in 1 CARTON > 15 mL in 1 CUP, UNIT-DOSE	6 carton	2019-05-03	0000-00-00	No	No	Current
0121-4577-15	00121457715	15 mL in 1 CUP, UNIT-DOSE (0121-4577-15)	15 ml	1966-07-30	0000-00-00	No	No	Current
0121-4577-40	00121457740	4 TRAY in 1 CASE (0121-4577-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15)	4 tray	1966-07-30	0000-00-00	No	No	Current
0121-4577-50	00121457750	5 TRAY in 1 CASE (0121-4577-50) / 5 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15)	5 tray	2022-11-19	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