Home NDC 66220-719 KRISTALOSE
Product NDC 66220-719
11-digit product format 662200719
Labeler code 66220
Product ID 66220-719_85528d56-e38f-4565-9136-c7639b479634
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lactulose
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Cumberland Pharmaceuticals Inc.
Application ANDA074712
Marketing category ANDA
Marketing start 2012-01-20
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 66220-719 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66220-719 66220-719-30 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074712-001 LACTULOSE LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 A074712-002 LACTULOSE LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10
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.
Product history page 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL AA RS 1997-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074712-001 LACTULOSE 10GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074712-002 LACTULOSE 20GM/PACKET FOR SOLUTION / ORAL RS 1997-12-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base KRISTALOSE
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251190 Internal RxNorm lookup 1251192 Internal RxNorm lookup 1251194 Internal RxNorm lookup 1251196 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 66220-719-01 KRISTALOSE 10 g in 1 POUCH POWDER, FOR SOLUTION 10 4 66220-719-30 KRISTALOSE 30 in 1 CARTON POWDER, FOR SOLUTION 30 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66220-719 KRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220927_535dd1ea-b567-49f7-9a84-8ea91e78c466.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 · 3 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 66220-719-01 66220071901 10 g in 1 POUCH 10 g Historical 66220-719-30 66220071930 30 POUCH in 1 CARTON (66220-719-30) / 10 g in 1 POUCH (66220-719-01) 30 pouch 2012-01-20 0000-00-00 No No Current