Home NDC 0121-0965 Lactulose
Product NDC 0121-0965
11-digit product format 001210965
Labeler code 0121
Product ID 0121-0965_e4873a34-cdc0-4c96-b04f-c84641f52236
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA217914
Marketing category ANDA
Marketing start 2025-03-17
Substance LACTULOSE
Active strength 10 g/10g
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217914-001 LACTULOSE LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 A217914-002 LACTULOSE LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A217914-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217914-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217914-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217914-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217914-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217914-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217914-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217914-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA 2025-03-14 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217914-001 CGT 2025-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217914-002 CGT 2025-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217914-001 CGT 2025-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217914-002 CGT 2025-09-13 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base Lactulose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTULOSE 10 g/10g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251190 Internal RxNorm lookup 1251194 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 0121-0965-01 Lactulose 10 g in 1 POUCH POWDER, FOR SOLUTION 10 3 0121-0965-30 Lactulose 30 in 1 CARTON POWDER, FOR SOLUTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0965 LACTULOSE POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 3 Current NDC, 2 package rows 20250321_5ae4b6da-44df-419a-9f2b-8c4d79f635c8.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 · 2 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 0121-0965-01 00121096501 10 g in 1 POUCH 10 g Historical 0121-0965-30 00121096530 30 POUCH in 1 CARTON (0121-0965-30) / 10 g in 1 POUCH (0121-0965-01) 30 pouch 2025-03-17 No No Current