Home NDC 60687-917 Lactulose
Product NDC 60687-917
11-digit product format 606870917
Labeler code 60687
Product ID 60687-917_5942b819-43c4-53a4-e063-6394a90af393
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler American Health Packaging
Application ANDA090503
Marketing category ANDA
Marketing start 2026-08-16
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090503-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2012-01-25 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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/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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60687-917-14 60687091714 4 TRAY in 1 CASE (60687-917-14) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-51) / 30 mL in 1 CUP, UNIT-DOSE (60687-917-45) 4 tray 2026-08-16 No No Current 60687-917-64 60687091764 4 TRAY in 1 CASE (60687-917-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-917-44) 4 tray 2026-08-16 No No Current 60687-917-76 60687091776 10 TRAY in 1 CASE (60687-917-76) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-51) / 30 mL in 1 CUP, UNIT-DOSE (60687-917-45) 10 tray 2026-08-16 No No Current