Home NDC 51672-4243 Lactulose
Product NDC 51672-4243
11-digit product format 516724243
Labeler code 51672
Product ID 51672-4243_3b8ff35a-8b5e-7aca-e063-6394a90aea34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA218858
Marketing category ANDA
Marketing start 2025-06-02
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 A218858-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218858-001 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.
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 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218858-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2024-12-13 a50c72e98297…
Observed Orange Book normalized TE history# 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 51672-4243-9 Lactulose 1 in 1 CARTON SOLUTION 1 5 51672-4243-9 Lactulose 473 mL in 1 BOTTLE SOLUTION 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4243 LACTULOSE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 Current NDC, 2 package rows 20250412_391cfd01-c1fa-41f9-abd7-d0abe9a27634.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 Sample Exclude flag Status 51672-4243-9 51672424309 1 BOTTLE in 1 CARTON (51672-4243-9) / 473 mL in 1 BOTTLE 1 bottle 2025-06-02 No No Current