Active ingredient
Lactulose
37 finished FDA listings contain Lactulose as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LACTULOSE
- Dosage forms
- Powder, For Solution, Solution
- Routes
- Oral, Rectal
- Manufacturers / labelers
- 22
- Strengths listed
- 10 g/10g · 10 g/15ml · 20 g/20g · 20 g/30ml
- Brand names in FDA listings
- Constulose, Enulose, Generlac, Kristalose, Lactulose Crystalline, Lactulose Solution
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6218
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 074623 | PHARM ASSOC | 1996-07-30 | 7 |
| ANDA 074603 | CHARTWELL RX | 1996-10-31 | 1 |
| ANDA 074712 | APOTEX | 1997-12-10 | 6 |
| ANDA 075993 | LANNETT CO INC | 2001-07-26 | 1 |
| ANDA 075911 | PHARMOBEDIENT | 2002-02-21 | 1 |
| ANDA 076645 | BAJAJ | 2003-07-28 | 4 |
| ANDA 090503 | FRESENIUS KABI | 2012-01-25 | 2 |
| ANDA 090502 | FRESENIUS KABI | 2012-01-25 | 3 |
| ANDA 203762 | APOZEAL PHARMS | 2015-03-27 | 1 |
| ANDA 207786 | APOZEAL PHARMS | 2018-06-11 | 1 |
| ANDA 209517 | CHARTWELL RX | 2018-11-23 | 5 |
| ANDA 218858 | TARO | 2024-12-13 | 1 |
| ANDA 217914 | PAI HOLDINGS | 2025-03-14 | 4 |
Official labeling on DailyMed
- LACTULOSE SOLUTION [AMERICAN HEALTH PACKAGING] · version 1 · 2026-08-20
- LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [KESIN PHARMA CORPORATION] · version 2 · 2026-08-14
- LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [KESIN PHARMA CORPORATION] · version 5 · 2026-08-14
- LACTULOSE SOLUTION [APOZEAL PHARMACEUTICALS INC] · version 4 · 2026-07-24
- LACTULOSE POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 4 · 2026-07-08
- LACTULOSE SOLUTION [CARDINAL HEALTH 107, LLC] · version 11 · 2026-06-01
- LACTULOSE SOLUTION [XTTRIUM LABORATORIES, INC.] · version 7 · 2026-04-22
- LACTULOSE SOLUTION [CHARTWELL RX, LLC] · version 5 · 2026-01-30
- LACTULOSE SOLUTION (LACTULOSE SOLUTION USP, 10 G/15 ML) SOLUTION [RISING PHARMA HOLDINGS, INC.] · version 3 · 2026-01-14
- LACTULOSE SOLUTION [APOZEAL PHARMACEUTICALS INC] · version 3 · 2026-01-07
- LACTULOSE SOLUTION [FOXLAND PHARMACEUTICALS, INC.] · version 9 · 2025-12-18
- LACTULOSE SOLUTION [CHARTWELL RX, LLC.] · version 4 · 2025-12-09
Showing the 12 most recent of 28 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.