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 |
|---|---|---|---|---|---|---|
| Eyewash Additive Concentrate | WATER AND PROPYLENE GLYCOL | Haws Corporation | dd168403-398c-41ff-b1df-d93e4ff39de3 | 2025-11-20 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | fd823bef-c14c-4708-a18a-8aaa8470412f | 2025-11-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Lactulose | LACTULOSE | Chartwell Governmental & Specialty RX, LLC. | 887157ba-3c91-4fbf-bb12-b49c6fa4252c | 2025-11-13 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 3765c251-eb14-d60f-e063-6294a90a6a4d | 2025-11-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37f244fd-c02f-e66a-e063-6394a90aed81 | 2025-11-12 | Warnings | 059QF0KO0R |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Becton Dickinson and Company | cab03cda-4660-4020-a3be-bf86242ff664 | 2025-10-22 | Warnings, Adverse reactions | 059QF0KO0R |
| 2a07047d-72aa-415e-ad5a-81e1f23c5c7f | 19455240-16b6-4e25-a5c9-a6c965e5ec19 | 2025-10-07 | Warnings, Adverse reactions | 19455240-16b6-4e25-a5c9-a6c965e5ec19 | ||
| Xpect Eyewash | EYEWASH | Cintas Corporation | 1d69365d-662b-4248-8fa9-1629451b549a | 2025-09-30 | Warnings | 059QF0KO0R |
| CheBoho TEA TREE ACNE | CHEBOHO TEA TREE ACNE | Opalshi(Guangzhou)E-commerce Co. Ltd. | 3fc4cf84-b2da-c593-e063-6394a90abc5c | 2025-09-27 | Warnings | 059QF0KO0R |
| LACTULOSE | LACTULOSE | Atlantic Biologicals Corp. | 3fb6e908-893c-5a57-e063-6294a90a1bfc | 2025-09-26 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Sterile Water | WATER | ProPharma Distribution | 3f2ae880-852f-b45d-e063-6394a90aa1cc | 2025-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| LACTULOSE | LACTULOSE | PAI Holdings, LLC dba PAI Pharma | 0f19e4ed-c90a-4330-a7fa-bf911aa98f09 | 2025-09-15 | Warnings, Adverse reactions | 9U7D5QH5AE |
| LACTULOSE | LACTULOSE | PAI Holdings, LLC dba PAI Pharma | cbf0497c-9c8d-4dfa-bebd-64c589468401 | 2025-09-15 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | Trifluent Pharma, Inc. | 3eaf273a-b49d-2595-e063-6394a90a1cf6 | 2025-09-13 | Warnings, Adverse reactions | 9U7D5QH5AE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.