Home NDC 0116-4005 Lactulose
Product NDC 0116-4005
11-digit product format 001164005
Labeler code 0116
Product ID 0116-4005_4f6f0368-4b59-a9df-e063-6294a90ae43c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler Xttrium Laboratories, Inc.
Application ANDA075911
Marketing category ANDA
Marketing start 2022-07-01
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 42 .
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 A075911-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075911-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL 2002-02-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL 2002-02-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075911-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2002-02-21 e64feba35796…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0116-4005 LACTULOSE SOLUTION [XTTRIUM LABORATORIES, INC.] 6 Current NDC, Legacy NDC, 11 package rows 20250514_df62ad54-5aba-4d05-e053-2a95a90aa48d.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 Marketing end Sample Exclude flag Status 0116-4005-08 00116400508 237 mL in 1 BOTTLE (0116-4005-08) 237 ml 2022-07-01 0000-00-00 No No Current 0116-4005-10 00116400510 100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) 100 case 2022-07-01 0000-00-00 No No Current 0116-4005-11 00116400511 100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) 100 case 2022-07-01 0000-00-00 No No Current 0116-4005-15 00116400515 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) 15 ml 2022-07-01 0000-00-00 No No Current 0116-4005-16 00116400516 473 mL in 1 BOTTLE (0116-4005-16) 473 ml 2022-07-01 0000-00-00 No No Current 0116-4005-30 00116400530 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) 30 ml 2022-07-01 0000-00-00 No No Current 0116-4005-32 00116400532 946 mL in 1 BOTTLE (0116-4005-32) 946 ml 2022-07-01 0000-00-00 No No Current 0116-4005-40 00116400540 10 in 1 TRAY Historical 0116-4005-41 00116400541 40 in 1 CASE Historical