LACTULOSE

Product NDC: 0121-1746
11-digit product format: 001211746
Labeler code: 0121
Product ID: 0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4
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: 2019-12-03
Substance: LACTULOSE
Active strength: 20 g/30mL
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

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	20 g/30mL

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
cbf0497c-9c8d-4dfa-bebd-64c589468401	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
0121-1746-00	LACTULOSE	10 in 1 CASE	SOLUTION	10	8
0121-1746-00	LACTULOSE	10 in 1 TRAY	SOLUTION	10	8
0121-1746-06	LACTULOSE	16 in 1 CARTON	SOLUTION	16	8
0121-1746-06	LACTULOSE	6 in 1 CASE	SOLUTION	6	8
0121-1746-30	LACTULOSE	30 mL in 1 CUP, UNIT-DOSE	SOLUTION	30	8
0121-1746-40	LACTULOSE	4 in 1 CASE	SOLUTION	4	8
0121-1746-40	LACTULOSE	10 in 1 TRAY	SOLUTION	10	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1746	LACTULOSE SOLUTION LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	7	Current NDC, Legacy NDC, 7 package rows	20240918_cbf0497c-9c8d-4dfa-bebd-64c589468401.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
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 ndc (product): 0121-1746
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	cbf0497c-9c8d-4dfa-bebd-64c589468401	8
391937	lactulose 667 MG/ML Oral Solution	SCD	cbf0497c-9c8d-4dfa-bebd-64c589468401	8
391937	lactulose 10 GM per 15 ML Oral Solution	SY	cbf0497c-9c8d-4dfa-bebd-64c589468401	8
391937	lactulose 20 GM per 30 ML Oral Solution	SY	cbf0497c-9c8d-4dfa-bebd-64c589468401	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1746-00	00121174600	10 TRAY in 1 CASE (0121-1746-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)	10 tray	2019-12-03	0000-00-00	No	No	Current
0121-1746-06	00121174606	6 CARTON in 1 CASE (0121-1746-06) / 16 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)	6 carton	2019-12-03	0000-00-00	No	No	Current
0121-1746-30	00121174630	30 mL in 1 CUP, UNIT-DOSE	30 ml					Historical
0121-1746-40	00121174640	4 TRAY in 1 CASE (0121-1746-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)	4 tray	2019-12-03	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	8