NDC 66220-729-01 - KRISTALOSE
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
- 66220-729
- Requested NDC
- 66220-729-01
- Package NDCs from labels
- 66220-729-01, 66220-729-30
- Manufacturer
- Cumberland Pharmaceuticals Inc.
- Effective date
- 2018-09-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| KRISTALOSE - Cumberland Pharmaceuticals Inc. | Cumberland Pharmaceuticals Inc. | 2018-09-17 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66220-729-30 | 2022-09-26 | C162847 | 48780-1 | e4f33bdf-9f2d-d8a0-e053-dadaa90a6e4e | KRISTALOSE ® (lactulose) For Oral Solution Cumberland Pharmaceuticals Inc. |
| 66220-729-30 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9f2d-d8a0-e053-dadaa90a6e4e | KRISTALOSE ® (lactulose) For Oral Solution Cumberland Pharmaceuticals Inc. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66220-729-01 | KRISTALOSE | 20 g in 1 POUCH | POWDER, FOR SOLUTION | 20 | 4 | |
| 66220-729-30 | KRISTALOSE | 30 in 1 CARTON | POWDER, FOR SOLUTION | 30 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66220-729-01 | EA - Each | 66220-729 | 5260405b-91fb-4542-9db3-524271fe0487 | 1 | 2013-08-02 |
| 66220-729-30 | EA - Each | 66220-729 | 8b6274f8-f701-4f6c-8e2c-c7d72c2a17b1 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| lactulose | ACTIVE INGREDIENT | 9U7D5QH5AE | KRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.] | 1 | |
| lactulose | ACTIVE MOIETY | 9U7D5QH5AE | KRISTALOSE (LACTULOSE) POWDER, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.] | 1 |
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 |
|---|---|---|---|---|---|---|
| Lactulose | LACTULOSE | American Health Packaging | 8b79d0d6-b9e3-436e-bab7-01451b6f45cd | 2026-08-17 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose Solution | LACTULOSE SOLUTION USP, 10 G/15 ML | Kesin Pharma Corporation | 163d5093-e35c-0bbf-e063-6294a90a803e | 2026-08-03 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose Solution | LACTULOSE SOLUTION USP, 10 G/15 ML | Kesin Pharma Corporation | 2d90e2a4-334f-ab68-e063-6294a90affa6 | 2026-08-03 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | APOZEAL PHARMACEUTICALS INC | 72ac130a-de85-464d-9e9b-05cac0c54db1 | 2026-07-23 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | PAI Holdings, LLC dba PAI Pharma | 5ae4b6da-44df-419a-9f2b-8c4d79f635c8 | 2026-07-07 | Warnings, Adverse reactions | 1251194 1251190 9U7D5QH5AE |
| LACTULOSE | LACTULOSE | Cardinal Health 107, LLC | 3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7 | 2026-05-19 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | Xttrium Laboratories, Inc. | df62ad54-5aba-4d05-e053-2a95a90aa48d | 2026-04-14 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | Chartwell RX, LLC | d6975cd8-80e0-43e2-809a-175ea7e40715 | 2026-01-28 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose Solution | LACTULOSE SOLUTION USP, 10 G/15 ML | Rising Pharma Holdings, Inc. | e75c335b-f19e-42e2-a24f-d891a52d3d34 | 2026-01-12 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | APOZEAL PHARMACEUTICALS INC | a8af7389-3699-4873-b05a-509af7e8eaab | 2026-01-06 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | Foxland Pharmaceuticals, Inc. | 3363bdbd-f0d1-45b3-8193-7fdb0a310cc2 | 2025-12-16 | Warnings, Adverse reactions | ANDA074712 1251194 1251190 9U7D5QH5AE |
| Lactulose | LACTULOSE | Chartwell RX, LLC. | bd9f1577-65e8-4521-b176-e5fc60a4a018 | 2025-12-08 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Lactulose | LACTULOSE | Chartwell Governmental & Specialty RX, LLC. | 887157ba-3c91-4fbf-bb12-b49c6fa4252c | 2025-11-13 | Warnings, Adverse reactions | 9U7D5QH5AE |
| LACTULOSE | LACTULOSE | Atlantic Biologicals Corp. | 3fb6e908-893c-5a57-e063-6294a90a1bfc | 2025-09-26 | Warnings, Adverse reactions | 9U7D5QH5AE |
| 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 | 1251194 1251190 9U7D5QH5AE |
| LACTULOSE Crystalline | LACTULOSE | Cumberland Assured Products Inc. | 59e75426-42ae-4904-941f-009181101a8a | 2025-09-01 | Warnings, Adverse reactions | ANDA074712 1251194 1251190 9U7D5QH5AE |
| Lactulose | LACTULOSE | Sun Pharmaceutical Industries, Inc. | 391cfd01-c1fa-41f9-abd7-d0abe9a27634 | 2025-08-04 | Warnings, Adverse reactions | 9U7D5QH5AE |
| Enulose | LACTULOSE | Bryant Ranch Prepack | fa3aae7c-6f98-4fbb-85dc-32affe9874d5 | 2024-12-18 | Warnings, Adverse reactions | 9U7D5QH5AE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.