Home NDC 13668-574-08 Lactulose
Product NDC 13668-574
Requested package NDC 13668-574-08
11-digit product format 136680574
Labeler code 13668
Product ID 13668-574_df4bb28b-5d74-2d55-e053-2995a90afc6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL; RECTAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA203762
Marketing category ANDA
Marketing start 2018-06-14
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 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 · 12 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…
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 A203762-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203762-001 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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 APOZEAL PHARMACEUTICALS INC a8af7389-3699-4873-b05a-509af7e8eaab 2026-01-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203762 application number: ANDA203762
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-574-08 13668057408 237 mL in 1 BOTTLE (13668-574-08) 237 ml 2018-06-14 0000-00-00 No No Current