Home NDC 83745-249 Lactulose
Product NDC 83745-249
11-digit product format 837450249
Labeler code 83745
Product ID 83745-249_2341cf95-5e57-47ab-9dc3-73afa86b786d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL; RECTAL
Labeler APOZEAL PHARMACEUTICALS INC
Application ANDA203762
Marketing category ANDA
Marketing start 2024-12-20
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 2027-12-31
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 · 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# Additional Listing Data#
Finished product Yes
Brand name base Lactulose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTULOSE 10 g/15mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 391937 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 83745-249-08 Lactulose 237 mL in 1 BOTTLE SOLUTION 237 3 83745-249-16 Lactulose 473 mL in 1 BOTTLE SOLUTION 473 3 83745-249-32 Lactulose 946 mL in 1 BOTTLE SOLUTION 946 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83745-249 LACTULOSE SOLUTION [APOZEAL PHARMACEUTICALS INC] 1 Current NDC, 3 package rows 20241222_a8af7389-3699-4873-b05a-509af7e8eaab.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83745-249-08 83745024908 237 mL in 1 BOTTLE (83745-249-08) 237 ml 2024-12-20 No No Current 83745-249-16 83745024916 473 mL in 1 BOTTLE (83745-249-16) 473 ml 2024-12-20 No No Current 83745-249-32 83745024932 946 mL in 1 BOTTLE (83745-249-32) 946 ml 2024-12-20 No No Current