Home NDC 0527-5125 LACTULOSE
Product NDC 0527-5125
11-digit product format 005275125
Labeler code 0527
Product ID 0527-5125_1b869904-b3c5-4f81-a333-1f26b6b2c7bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LACTULOSE
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA075993
Marketing category ANDA
Marketing start 2001-07-26
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075993-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075993-001 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 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075993-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2001-07-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/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 0527-5125-68 LACTULOSE 237 mL in 1 BOTTLE SOLUTION 237 10 0527-5125-70 LACTULOSE 473 mL in 1 BOTTLE SOLUTION 473 10 0527-5125-78 LACTULOSE 946 mL in 1 BOTTLE SOLUTION 946 10 0527-5125-82 LACTULOSE 1892 mL in 1 BOTTLE SOLUTION 1892 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-5125 LACTULOSE SOLUTION [LANNETT COMPANY, INC.] 10 Current NDC, Legacy NDC, 4 package rows 20210714_6619b25c-26b7-4c43-8c4f-9d33a23c61ca.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 0527-5125-68 00527512568 237 mL in 1 BOTTLE (0527-5125-68) 237 ml 2001-07-26 0000-00-00 No No Current 0527-5125-70 00527512570 473 mL in 1 BOTTLE (0527-5125-70) 473 ml 2001-07-26 0000-00-00 No No Current 0527-5125-78 00527512578 946 mL in 1 BOTTLE (0527-5125-78) 946 ml 2001-07-26 0000-00-00 No No Current 0527-5125-82 00527512582 1892 mL in 1 BOTTLE (0527-5125-82) 1892 ml 2001-07-26 0000-00-00 No No Current