Home NDC 82804-107 LACTULOSE
Product NDC 82804-107
11-digit product format 828040107
Labeler code 82804
Product ID 82804-107_6bbabdc6-f6a8-4f67-a448-e452d1928deb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler Proficient Rx LP
Application ANDA074623
Marketing category ANDA
Marketing start 2019-12-03
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 A074623-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074623-001 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 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 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 82804-107-47 LACTULOSE 473 mL in 1 BOTTLE SOLUTION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-107 LACTULOSE SOLUTION [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20240622_6bbabdc6-f6a8-4f67-a448-e452d1928deb.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LACTULOSE LACTULOSE Cardinal Health 107, LLC 3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7 2026-05-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE Atlantic Biologicals Corp. 3fb6e908-893c-5a57-e063-6294a90a1bfc 2025-09-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE PAI Holdings, LLC dba PAI Pharma 0f19e4ed-c90a-4330-a7fa-bf911aa98f09 2025-09-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE PAI Holdings, LLC dba PAI Pharma cbf0497c-9c8d-4dfa-bebd-64c589468401 2025-09-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE Proficient Rx LP 6bbabdc6-f6a8-4f67-a448-e452d1928deb 2024-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 ndc (product): 82804-107
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-107-47 82804010747 473 mL in 1 BOTTLE (82804-107-47) 473 ml 2024-06-14 No No Current