Home NDC 62135-003 Lactulose
Product NDC 62135-003
11-digit product format 621350003
Labeler code 62135
Product ID 62135-003_456e6761-40f8-db90-e063-6394a90a2393
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lactulose
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA209517
Marketing category ANDA
Marketing start 2018-11-23
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 A209517-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209517-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209517-001 LACTULOSE 10GM/15ML SOLUTION / ORAL AA 2018-11-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 62135-003-37 Lactulose 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 4 62135-003-47 Lactulose 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 4 62135-003-78 Lactulose 3785 mL in 1 BOTTLE, PLASTIC SOLUTION 3785 4 62135-003-94 Lactulose 946 mL in 1 BOTTLE, PLASTIC SOLUTION 946 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-003 LACTULOSE SOLUTION [CHARTWELL RX, LLC.] 3 Current NDC, Legacy NDC, 4 package rows 20241030_bd9f1577-65e8-4521-b176-e5fc60a4a018.zip
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 62135-003-37 62135000337 237 mL in 1 BOTTLE, PLASTIC (62135-003-37) 237 ml 2021-01-10 0000-00-00 No No Current 62135-003-47 62135000347 473 mL in 1 BOTTLE, PLASTIC (62135-003-47) 473 ml 2021-01-10 0000-00-00 No No Current 62135-003-78 62135000378 3785 mL in 1 BOTTLE, PLASTIC (62135-003-78) 3785 ml 2021-01-10 0000-00-00 No No Current 62135-003-94 62135000394 946 mL in 1 BOTTLE, PLASTIC (62135-003-94) 946 ml 2021-01-10 0000-00-00 No No Current