Home NDC 50090-3436-0 Constulose
Product NDC 50090-3436
Requested package NDC 50090-3436-0
11-digit product format 500903436
Labeler code 50090
Product ID 50090-3436_a0bed20c-bdb6-42a7-84ec-676852a0a352
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler A-S Medication Solutions
Application ANDA090503
Marketing category ANDA
Marketing start 2011-02-28
Marketing end 0000-00-00
Substance LACTULOSE
Active strength 10 g/15mL
Pharmacologic classes Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A090503-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090503-001 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 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3436-0 Constulose 237 mL in 1 BOTTLE SOLUTION 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3436 CONSTULOSE (LACTULOSE) SOLUTION [A-S MEDICATION SOLUTIONS] 4 Legacy NDC, 1 package rows 20210303_f34607bc-d4d3-4997-b4fb-1950efbc15ba.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 50090-3436-0 50090343600 237 mL in 1 BOTTLE (50090-3436-0) 237 ml 2018-04-16 0000-00-00 No No Current