Generlac

Product NDC: 60432-038
11-digit product format: 604320038
Labeler code: 60432
Product ID: 60432-038_48f7403f-d257-41a6-a871-fb233c6ef8e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lactulose
Dosage form: SOLUTION
Route: ORAL; RECTAL
Labeler: Morton Grove Pharmaceuticals, Inc.
Application: ANDA074603
Marketing category: ANDA
Marketing start: 1996-10-31
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: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60432-038		D	Discontinued by firm	2026-08-10
excluded package	package	60432-038	60432-038-16	D	Discontinued by firm	2026-08-10
excluded package	package	60432-038	60432-038-64	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60432-038-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60432-038-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60432-038-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60432-038-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60432-038-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60432-038-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60432-038-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60432-038-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60432-038-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60432-038-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60432-038-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60432-038-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60432-038-64	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60432-038-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60432-038-64	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60432-038-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60432-038-64	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60432-038-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60432-038-64	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60432-038-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60432-038-64	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60432-038-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60432-038-64	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60432-038-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60432-038-64	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60432-038-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60432-038-64	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60432-038-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60432-038-64	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60432-038-16	`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
A074603-001	GENERLAC	LACTULOSE	10GM/15ML	SOLUTION / ORAL, RECTAL	AA		1996-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074603-001	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	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074603-001	GENERLAC	10GM/15ML	SOLUTION / ORAL, RECTAL	AA	1996-10-31	`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	A074603-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074603-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074603-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074603-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074603-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074603-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074603-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074603-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074603-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074603-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074603-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074603-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074603-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074603-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074603-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074603-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074603-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074603-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074603-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074603-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074603-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074603-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074603-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074603-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074603-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074603-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074603-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074603-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074603-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074603-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074603-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074603-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074603-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074603-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074603-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074603-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074603-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074603-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074603-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074603-001	AA	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
60432-038-16	2025-12-08	GENERLAC SOLUTION 10 g/15 mL (Lactulose Solution, USP) For Oral or Rectal Administration Rx only
60432-038-64	2025-12-08	GENERLAC SOLUTION 10 g/15 mL (Lactulose Solution, USP) For Oral or Rectal Administration Rx only
60432-038-16	2023-01-30	GENERLAC SOLUTION 10 g/15 mL (Lactulose Solution, USP) For Oral or Rectal Administration Rx only
60432-038-64	2023-01-30	GENERLAC SOLUTION 10 g/15 mL (Lactulose Solution, USP) For Oral or Rectal Administration Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-038-16	ML - Milliliter	60432-038	08acb287-1167-4215-8f20-094e9c06d294	1	2012-07-24
60432-038-64	ML - Milliliter	60432-038	ead49c83-ae97-4c2c-a95e-faa28e3c028c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Lactulose	ACTIVE INGREDIENT	9U7D5QH5AE	GENERLAC (LACTULOSE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	3
Lactulose	ACTIVE MOIETY	9U7D5QH5AE	GENERLAC (LACTULOSE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-038	GENERLAC (LACTULOSE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	6	Legacy NDC	20190108_2a2eee86-273e-4718-8f78-34f15e193040.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
Generlac	LACTULOSE	Chartwell RX, LLC	35207edd-a5fe-4369-a079-7a8b0d2f2e91	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074603 application number: ANDA074603

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60432-038-16	60432003816	473 mL in 1 BOTTLE, PLASTIC (60432-038-16)	473 ml	1996-10-31	0000-00-00	No	No	Current
60432-038-64	60432003864	1892 mL in 1 BOTTLE, PLASTIC (60432-038-64)	1892 ml	1996-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GENERLAC SOLUTION 10 g/15 mL (Lactulose Solution, USP) For Oral or Rectal Administration Rx only	Morton Grove Pharmaceuticals, Inc.	2019-01-08	HUMAN PRESCRIPTION DRUG LABEL	6