Home NDC 69067-010 Lactulose
Product NDC 69067-010
11-digit product format 690670010
Labeler code 69067
Product ID 69067-010_4618824a-2b40-3d54-e063-6394a90a4b96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler Foxland Pharmaceuticals, Inc.
Application ANDA074712
Marketing category ANDA
Marketing start 2018-09-21
Substance LACTULOSE
Active strength 10 g/10g
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTULOSE 10 g/10g
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 69067-010-15 Lactulose 10 g in 1 POUCH SOLUTION 10 9 69067-010-15 Lactulose 15 in 1 CARTON SOLUTION 15 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69067-010 LACTULOSE SOLUTION [FOXLAND PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250426_3363bdbd-f0d1-45b3-8193-7fdb0a310cc2.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69067-010-15 69067001015 15 POUCH in 1 CARTON (69067-010-15) / 10 g in 1 POUCH 15 pouch 2018-09-21 0000-00-00 No No Current