Home NDC 85592-829 LACTULOSE
Product NDC 85592-829
11-digit product format 855920829
Labeler code 85592
Product ID 85592-829_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lactulose
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Cumberland Assured Products Inc.
Application ANDA074712
Marketing category ANDA
Marketing start 2025-09-01
Substance LACTULOSE
Active strength 20 g/20g
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074712-001 LACTULOSE LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 A074712-002 LACTULOSE LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base LACTULOSE
Brand name suffix Crystalline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTULOSE 20 g/20g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251190 Internal RxNorm lookup 1251194 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85592-829-01 LACTULOSE Crystalline 20 g in 1 POUCH POWDER, FOR SOLUTION 20 2 85592-829-30 LACTULOSE Crystalline 30 in 1 CARTON POWDER, FOR SOLUTION 30 2
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85592-829-01 85592082901 20 g in 1 POUCH 20 g Historical 85592-829-30 85592082930 30 POUCH in 1 CARTON (85592-829-30) / 20 g in 1 POUCH (85592-829-01) 30 pouch 2025-09-01 No No Current