NDC 50383-357-30 - 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
- 50383-357
- Requested NDC
- 50383-357-30
- Package NDCs from labels
- 50383-357-30, 50383-357-33, 50383-357-31
- Manufacturer
- Akorn | Akorn Operating Company LLC
- Effective date
- 2023-01-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Lactulose - Akorn | Akorn Operating Company LLC | Akorn | Akorn Operating Company LLC | 2023-01-17 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50383-357-31 | 2024-07-30 | LACTULOSE SOLUTION, USP |
| 50383-357-33 | 2024-07-30 | LACTULOSE SOLUTION, USP |
| 50383-357-31 | 2024-01-30 | LACTULOSE SOLUTION, USP |
| 50383-357-33 | 2024-01-30 | LACTULOSE SOLUTION, USP |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50383-357-30 | ML - Milliliter | 50383-357 | 58bb0061-215d-4353-845f-6024940ed419 | 1 | 2023-02-06 |
| 50383-357-31 | ML - Milliliter | 50383-357 | 158b33e4-9ed1-4b06-a3a9-7154053200eb | 1 | 2023-02-06 |
| 50383-357-33 | ML - Milliliter | 50383-357 | bcb159ec-e1cd-4699-96eb-c8f35825183f | 1 | 2023-02-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LACTULOSE | ACTIVE INGREDIENT | 9U7D5QH5AE | LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| LACTULOSE | ACTIVE MOIETY | 9U7D5QH5AE | LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| GALACTOSE | INACTIVE INGREDIENT | X2RN3Q8DNE | LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LACTULOSE SOLUTION [HI-TECH PHARMACAL CO., INC.] | 3 |
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 |
|---|---|---|---|---|---|---|
| Sterile Water | STERILE WATER | Hikma Pharmaceuticals USA Inc. | b20a28b0-7dfa-42eb-9177-ec256d5a5ef7 | 2023-05-08 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Civica, Inc. | 3f49eedf-5bf5-4a95-b704-c956d860ca04 | 2023-04-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Treprostinil | TREPROSTINIL | Sandoz Inc | 473297ca-a872-4052-a053-87dc8f0d3c13 | 2023-04-06 | Warnings, Adverse reactions | 059QF0KO0R |
| NOVOLOG | INSULIN ASPART | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | 059QF0KO0R |
| 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 | 9U7D5QH5AE |
| Lactulose | LACTULOSE | Fresenius Kabi Austria GmbH | a89835c9-8ce5-4627-8d7d-70ff175b2e07 | 2022-11-09 | Adverse reactions | 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 | 9U7D5QH5AE |
| Enulose | LACTULOSE | Actavis Pharma, Inc. | 00c42c5c-d19e-4130-aa08-a8bbd47d3e5b | 2022-06-01 | Warnings, Adverse reactions | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.