NDC 0116-4005-41 - Lactulose
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0116-4005
- Requested NDC
- 0116-4005-41
- Package NDCs from labels
- 0116-4005-08, 0116-4005-16, 0116-4005-32, 0116-4005-15, 0116-4005-40, 0116-4005-10, 0116-4005-30, 0116-4005-41, 0116-4005-11
- Manufacturer
- Xttrium Laboratories, Inc.
- Effective date
- 2026-04-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| LACTULOSE SOLUTION, USP | Xttrium Laboratories, Inc. | 2026-04-14 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0116-4005-08 | Lactulose | 237 mL in 1 BOTTLE | SOLUTION | 237 | 7 | |
| 0116-4005-10 | Lactulose | 100 in 1 CASE | SOLUTION | 100 | 7 | |
| 0116-4005-11 | Lactulose | 100 in 1 CASE | SOLUTION | 100 | 7 | |
| 0116-4005-15 | Lactulose | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | 7 | |
| 0116-4005-16 | Lactulose | 473 mL in 1 BOTTLE | SOLUTION | 473 | 7 | |
| 0116-4005-30 | Lactulose | 30 mL in 1 CUP, UNIT-DOSE | SOLUTION | 30 | 7 | |
| 0116-4005-32 | Lactulose | 946 mL in 1 BOTTLE | SOLUTION | 946 | 7 | |
| 0116-4005-40 | Lactulose | 10 in 1 TRAY | SOLUTION | 10 | 7 | |
| 0116-4005-40 | Lactulose | 40 in 1 CASE | SOLUTION | 40 | 7 | |
| 0116-4005-41 | Lactulose | 40 in 1 CASE | SOLUTION | 40 | 7 | |
| 0116-4005-41 | Lactulose | 10 in 1 TRAY | SOLUTION | 10 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0116-4005-08 | ML - Milliliter | 0116-4005 | f7ea2d68-651b-40ae-b2f8-a3eb54ef076f | 1 | 2023-10-16 |
| 0116-4005-11 | ML - Milliliter | 0116-4005 | 6ba03cdd-584d-42d1-9502-0a036d3803df | 1 | 2024-02-14 |
| 0116-4005-15 | ML - Milliliter | 0116-4005 | 11777ba0-6857-4c8d-8508-c3829847a24e | 1 | 2024-02-14 |
| 0116-4005-16 | ML - Milliliter | 0116-4005 | 3451d8c5-188f-4933-aba3-ae2f8e0fdbe5 | 1 | 2023-04-07 |
| 0116-4005-30 | ML - Milliliter | 0116-4005 | f1c0f6c8-48e0-41a6-b878-6217959a4721 | 1 | 2024-02-14 |
| 0116-4005-32 | ML - Milliliter | 0116-4005 | 23ad189f-3f05-4fb3-b711-3cb594e89280 | 1 | 2024-02-14 |
| 0116-4005-40 | ML - Milliliter | 0116-4005 | 69479b61-fb23-48cd-b159-002da8f34bb2 | 1 | 2024-02-14 |
| 0116-4005-41 | ML - Milliliter | 0116-4005 | 6725bfb2-3713-441f-96d1-afc7805d5263 | 1 | 2024-02-14 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R |
| Lactulose Solution | LACTULOSE SOLUTION USP, 10 G/15 ML | Bajaj Medical, LLC | d460b1a2-9091-2ac9-e053-2995a90aa1d2 | 2022-12-26 | Warnings, Adverse reactions | 391937 9U7D5QH5AE |
| Lactulose | LACTULOSE | Fresenius Kabi Austria GmbH | a89835c9-8ce5-4627-8d7d-70ff175b2e07 | 2022-11-09 | Adverse reactions | 391937 9U7D5QH5AE |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Constulose | LACTULOSE | Actavis Pharma, Inc. | 461ec39f-eeb4-4460-9b5c-62367d47162b | 2022-06-01 | Warnings, Adverse reactions | 391937 9U7D5QH5AE |
| Enulose | LACTULOSE | Actavis Pharma, Inc. | 00c42c5c-d19e-4130-aa08-a8bbd47d3e5b | 2022-06-01 | Warnings, Adverse reactions | 391937 9U7D5QH5AE |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| LACTULOSE | LACTULOSE | Lannett Company, Inc. | 6619b25c-26b7-4c43-8c4f-9d33a23c61ca | 2020-01-30 | Warnings, Adverse reactions | 391937 9U7D5QH5AE |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.