Home NDC 55154-9448 LACTULOSE
Product NDC 55154-9448
11-digit product format 551549448
Labeler code 55154
Product ID 55154-9448_c6c822e7-9486-4ad9-81a2-c2b8ee692f32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LACTULOSE
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA074623
Marketing category ANDA
Marketing start 1966-07-30
Substance LACTULOSE
Active strength 20 g/30mL
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074623-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074623-001 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 · 42 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 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA RS 1996-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074623-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 1996-07-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LACTULOSE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTULOSE 20 g/30mL
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 55154-9448-5 LACTULOSE 30 mL in 1 CUP, UNIT-DOSE SOLUTION 30 10 55154-9448-5 LACTULOSE 5 in 1 BAG SOLUTION 5 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-9448 LACTULOSE SOLUTION [CARDINAL HEALTH 107, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250403_3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LACTULOSE LACTULOSE Cardinal Health 107, LLC 3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7 2026-05-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 ndc (product): 55154-9448 LACTULOSE LACTULOSE Atlantic Biologicals Corp. 3fb6e908-893c-5a57-e063-6294a90a1bfc 2025-09-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE PAI Holdings, LLC dba PAI Pharma 0f19e4ed-c90a-4330-a7fa-bf911aa98f09 2025-09-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE PAI Holdings, LLC dba PAI Pharma cbf0497c-9c8d-4dfa-bebd-64c589468401 2025-09-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623 LACTULOSE LACTULOSE Proficient Rx LP 6bbabdc6-f6a8-4f67-a448-e452d1928deb 2024-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074623 application number: ANDA074623
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-9448-5 55154944805 5 CUP, UNIT-DOSE in 1 BAG (55154-9448-5) / 30 mL in 1 CUP, UNIT-DOSE 1966-07-30 2022-01-31 No No Current