LACTULOSE
- Product NDC
- 0121-4577
- 11-digit product format
- 001214577
- Labeler code
- 0121
- Product ID
- 0121-4577_6843c997-c52c-4978-b087-647f7c3fa782
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LACTULOSE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA074623
- Marketing category
- ANDA
- Marketing start
- 1966-07-30
- Substance
- LACTULOSE
- Active strength
- 10 g/15mL
- Pharmacologic classes
- Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LACTULOSE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACTULOSE | 10 g/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9U7D5QH5AE |
| Rxcui | 391937 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LACTULOSE | ACTIVE INGREDIENT | 9U7D5QH5AE | LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,] | 4 | |
| LACTULOSE | ACTIVE MOIETY | 9U7D5QH5AE | LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LACTULOSE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC,] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-4577 | LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 21 | Current NDC, Legacy NDC, 7 package rows | 20241114_0f19e4ed-c90a-4330-a7fa-bf911aa98f09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-4577-06 | 00121457706 | 6 CARTON in 1 CASE (0121-4577-06) > 16 CUP, UNIT-DOSE in 1 CARTON > 15 mL in 1 CUP, UNIT-DOSE | 6 carton | 2019-05-03 | 0000-00-00 | No | No | Current |
| 0121-4577-15 | 00121457715 | 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15) | 15 ml | 1966-07-30 | 0000-00-00 | No | No | Current |
| 0121-4577-40 | 00121457740 | 4 TRAY in 1 CASE (0121-4577-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15) | 4 tray | 1966-07-30 | 0000-00-00 | No | No | Current |
| 0121-4577-50 | 00121457750 | 5 TRAY in 1 CASE (0121-4577-50) / 5 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15) | 5 tray | 2022-11-19 | 0000-00-00 | No | No | Current |