Home NDC 80432-001 Lactulose Solution
Product NDC 80432-001
11-digit product format 804320001
Labeler code 80432
Product ID 80432-001_f1f0ab04-0096-9db4-e053-2995a90aa04c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose Solution
Dosage form SOLUTION
Route ORAL
Labeler TriRx Huntsville Pharmaceutical Services, LLC
Application ANDA075993
Marketing category ANDA
Marketing start 2020-01-01
Marketing end 0000-00-00
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 2024-12-31
Current FDA listing Historical FDA.report record 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80432-001-33 80432000133 473 mL in 1 BOTTLE, PLASTIC (80432-001-33) 473 ml 2020-01-01 0000-00-00 No No Current 80432-001-35 80432000135 946 mL in 1 BOTTLE, PLASTIC (80432-001-35) 946 ml 2020-01-01 0000-00-00 No No Current