Lactulose

Product NDC: 50383-779
11-digit product format: 503830779
Labeler code: 50383
Product ID: 50383-779_9e355a5d-ef2c-4c39-b511-fd9b7ceb6faf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA074076
Marketing category: ANDA
Marketing start: 1995-07-03
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

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-779		D	Discontinued by firm	2026-08-10
excluded package	package	50383-779	50383-779-08	D	Discontinued by firm	2026-08-10
excluded package	package	50383-779	50383-779-16	D	Discontinued by firm	2026-08-10
excluded package	package	50383-779	50383-779-17	D	Discontinued by firm	2026-08-10
excluded package	package	50383-779	50383-779-31	D	Discontinued by firm	2026-08-10
excluded package	package	50383-779	50383-779-32	D	Discontinued by firm	2026-08-10
excluded package	package	50383-779	50383-779-33	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 2 · 80 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-779-08	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-779-32	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-779-31	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-779-17	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-779-33	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-779-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-779-33	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-779-08	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-779-32	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-779-17	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-779-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-779-31	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-779-33	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-779-08	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-779-32	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-779-17	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-779-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-779-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-779-33	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-779-08	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-779-32	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-779-17	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-779-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-779-31	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-779-33	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-779-08	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-779-32	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-779-17	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-779-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-779-31	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-779-33	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-779-08	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-779-32	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-779-17	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-779-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-779-31	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-779-33	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-779-08	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-779-32	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-779-17	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-779-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-779-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-779-33	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-779-08	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-779-32	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-779-17	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-779-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-779-31	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-779-33	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-779-08	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-779-32	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`

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
A074076-001	LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03

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	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL			1995-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074076-001	LACTULOSE	10GM/15ML	SOLUTION / ORAL	AA	RS	1995-07-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074076-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074076-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074076-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074076-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074076-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074076-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074076-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074076-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074076-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074076-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074076-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074076-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074076-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074076-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074076-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074076-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074076-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074076-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074076-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074076-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074076-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074076-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074076-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074076-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074076-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074076-001	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, Related label table
NDC	Effective	Related label
50383-779-08	2024-07-30	LACTULOSE SOLUTION, USP
50383-779-16	2024-07-30	LACTULOSE SOLUTION, USP
50383-779-17	2024-07-30	LACTULOSE SOLUTION, USP
50383-779-31	2024-07-30	LACTULOSE SOLUTION, USP
50383-779-32	2024-07-30	LACTULOSE SOLUTION, USP
50383-779-33	2024-07-30	LACTULOSE SOLUTION, USP
50383-779-08	2024-01-30	LACTULOSE SOLUTION, USP
50383-779-16	2024-01-30	LACTULOSE SOLUTION, USP
50383-779-17	2024-01-30	LACTULOSE SOLUTION, USP
50383-779-31	2024-01-30	LACTULOSE SOLUTION, USP
50383-779-32	2024-01-30	LACTULOSE SOLUTION, USP
50383-779-33	2024-01-30	LACTULOSE SOLUTION, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-779-08	ML - Milliliter	50383-779	fde82a52-aa05-4816-8685-c9ff286429df	1	2012-07-24
50383-779-15	ML - Milliliter	50383-779	d29ee989-30d6-4102-ad6d-609458b99083	1	2012-07-24
50383-779-16	ML - Milliliter	50383-779	c348a4fa-126e-458b-87c9-933e9e6ef54d	1	2012-07-24
50383-779-17	ML - Milliliter	50383-779	f3900f5f-ad8a-437a-99ff-47000c02a248	1	2013-05-02
50383-779-30	ML - Milliliter	50383-779	14c0cd30-345a-41b8-9f30-f6ff5b5f5d3a	1	2012-07-24
50383-779-31	ML - Milliliter	50383-779	28c7648a-ae73-4704-87f7-57bb22f0dd6d	1	2013-05-02
50383-779-32	ML - Milliliter	50383-779	548dec33-f807-4a61-96b7-30344bf46b7c	1	2012-07-24
50383-779-33	ML - Milliliter	50383-779	fe2b6e67-526f-4524-93af-209ecdce0d63	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
GALACTOSE	INACTIVE INGREDIENT	X2RN3Q8DNE	LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
LACTULOSE	ACTIVE INGREDIENT	9U7D5QH5AE	LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
LACTULOSE	ACTIVE MOIETY	9U7D5QH5AE	LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
GALACTOSE	INACTIVE INGREDIENT	X2RN3Q8DNE	LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LACTULOSE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-779	LACTULOSE SOLUTION [AKORN]	9	Legacy NDC	20230120_19455240-16b6-4e25-a5c9-a6c965e5ec19.zip

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	a5a5747b-5194-43a9-8307-f1e05c6eacb4	1
391937	lactulose 667 MG/ML Oral Solution	SCD	a5a5747b-5194-43a9-8307-f1e05c6eacb4	1
391937	lactulose 10 GM per 15 ML Oral Solution	SY	a5a5747b-5194-43a9-8307-f1e05c6eacb4	1
391937	lactulose 20 GM per 30 ML Oral Solution	SY	a5a5747b-5194-43a9-8307-f1e05c6eacb4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-779-08	50383077908	237 mL in 1 BOTTLE (50383-779-08)	237 ml	1995-07-03	0000-00-00	No	No	Current
50383-779-16	50383077916	473 mL in 1 BOTTLE (50383-779-16)	473 ml	1995-07-03	0000-00-00	No	No	Current
50383-779-17	50383077917	4 TRAY in 1 CASE (50383-779-17) > 10 CUP in 1 TRAY (50383-779-15) > 15 mL in 1 CUP	4 tray	2009-09-04	0000-00-00	No	No	Current
50383-779-31	50383077931	4 TRAY in 1 CASE (50383-779-31) > 10 CUP in 1 TRAY (50383-779-30) > 30 mL in 1 CUP	4 tray	2009-09-04	0000-00-00	No	No	Current
50383-779-32	50383077932	946 mL in 1 BOTTLE (50383-779-32)	946 ml	1995-07-03	0000-00-00	No	No	Current
50383-779-33	50383077933	10 TRAY in 1 CASE (50383-779-33) > 10 CUP in 1 TRAY > 30 mL in 1 CUP	10 tray	2009-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LACTULOSE SOLUTION, USP	Akorn \| Akorn Operating Company LLC	2023-01-17	HUMAN PRESCRIPTION DRUG LABEL	9
LACTULOSE SOLUTION, USP	Aidarex Pharmaceuticals LLC	2013-10-02	HUMAN PRESCRIPTION DRUG LABEL	1