Home NDC 64980-592 Lactulose Solution
Product NDC 64980-592
11-digit product format 649800592
Labeler code 64980
Product ID 64980-592_ae4387e8-ba31-4378-9e67-98effdcc998f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose Solution USP, 10 g/15 mL
Dosage form SOLUTION
Route ORAL; RECTAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA076645
Marketing category ANDA
Marketing start 2021-10-14
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 A076645-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076645-001 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 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2003-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076645-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2003-07-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lactulose Solution
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 64980-592-12 Lactulose Solution 118 mL in 1 BOTTLE SOLUTION 118 3 64980-592-24 Lactulose Solution 236 mL in 1 BOTTLE SOLUTION 236 3 64980-592-48 Lactulose Solution 473 mL in 1 BOTTLE SOLUTION 473 3 64980-592-95 Lactulose Solution 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 64980-592 LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [RISING PHARMACEUTICALS, INC.] 2 Current NDC, 4 package rows 20230602_e75c335b-f19e-42e2-a24f-d891a52d3d34.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lactulose Solution LACTULOSE SOLUTION USP, 10 G/15 ML Rising Pharma Holdings, Inc. e75c335b-f19e-42e2-a24f-d891a52d3d34 2026-01-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076645 application number: ANDA076645 ndc (product): 64980-592 Lactulose Solution LACTULOSE SOLUTION USP, 10 G/15 ML Kesin Pharma Corporation 2d90e2a4-334f-ab68-e063-6294a90affa6 2025-02-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076645 application number: ANDA076645 Lactulose Solution LACTULOSE SOLUTION USP, 10 G/15 ML Bajaj Medical, LLC d460b1a2-9091-2ac9-e053-2995a90aa1d2 2022-12-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076645 application number: ANDA076645
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-592-12 64980059212 118 mL in 1 BOTTLE (64980-592-12) 118 ml 2023-05-25 No No Current 64980-592-24 64980059224 236 mL in 1 BOTTLE (64980-592-24) 236 ml 2023-05-25 No No Current 64980-592-48 64980059248 473 mL in 1 BOTTLE (64980-592-48) 473 ml 2023-05-25 No No Current 64980-592-95 64980059295 946 mL in 1 BOTTLE (64980-592-95) 946 ml 2023-05-25 No No Current