Lactulose

Product NDC: 17856-1378
Requested package NDC: 17856-1378-2
11-digit product format: 178561378
Labeler code: 17856
Product ID: 17856-1378_fa34b11e-85d6-4c9e-bc71-3db28dd39ec3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lactulose
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: ANDA075993
Marketing category: ANDA
Marketing start: 2001-07-26
Marketing end: 0000-00-00
Substance: LACTULOSE
Active strength: 10 g/15mL
Pharmacologic classes: Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	17856-1378	17856-1378-2	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A075993-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA		2001-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075993-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075993-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	2001-07-26	`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	A075993-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075993-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075993-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075993-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075993-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075993-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075993-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075993-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075993-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075993-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075993-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075993-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075993-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075993-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075993-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075993-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075993-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075993-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075993-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075993-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075993-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075993-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075993-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075993-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075993-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075993-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075993-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075993-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075993-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075993-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075993-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075993-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075993-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075993-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075993-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075993-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075993-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075993-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075993-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075993-001	AA	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-1378-1	2023-01-30	C162847	48780-1	f386c64a-2247-0266-e053-dadaa90a7c1a	LACTULOSE SOLUTION, USP Rx only
17856-1378-2	2023-01-30	C162847	48780-1	f386c64a-2247-0266-e053-dadaa90a7c1a	LACTULOSE SOLUTION, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-1378-1	Lactulose	30 mL in 1 CUP	SOLUTION	30		6
17856-1378-2	Lactulose	15 mL in 1 CUP	SOLUTION	15		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-1378-1	ML - Milliliter	17856-1378	64f4ad95-fa33-4fda-a3a2-0bc5304f7f1a	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-1378	LACTULOSE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	6	Legacy NDC, 2 package rows	20210129_287b0b8b-962b-4f05-b770-5dc9d170d1d0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACTULOSE	LACTULOSE	Lannett Company, Inc.	6619b25c-26b7-4c43-8c4f-9d33a23c61ca	2020-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075993 application number: ANDA075993

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	287b0b8b-962b-4f05-b770-5dc9d170d1d0	6
391937	lactulose 667 MG/ML Oral Solution	SCD	287b0b8b-962b-4f05-b770-5dc9d170d1d0	6
391937	lactulose 10 GM per 15 ML Oral Solution	SY	287b0b8b-962b-4f05-b770-5dc9d170d1d0	6
391937	lactulose 20 GM per 30 ML Oral Solution	SY	287b0b8b-962b-4f05-b770-5dc9d170d1d0	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-1378-2	17856137802	15 mL in 1 CUP (17856-1378-2)	15 ml	2021-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LACTULOSE SOLUTION, USP Rx only	Atlantic Biologicals Corps	2021-01-28	HUMAN PRESCRIPTION DRUG LABEL	6