LACTULOSE
- Product NDC
- 0121-0873
- 11-digit product format
- 001210873
- Labeler code
- 0121
- Product ID
- 0121-0873_b73c2ddc-a690-46e1-aa89-40fa890c9ab4
- 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
- 2019-12-03
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0873-08 | LACTULOSE | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 8 |
| 0121-0873-15 | LACTULOSE | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 8 |
| 0121-0873-16 | LACTULOSE | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 8 |
| 0121-0873-32 | LACTULOSE | 946 mL in 1 BOTTLE | SOLUTION | 946 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0873 | LACTULOSE SOLUTION LACTULOSE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240918_cbf0497c-9c8d-4dfa-bebd-64c589468401.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 |
|---|
| 0121-0873-06 | 00121087306 | 6 CARTON in 1 CASE (0121-0873-06) > 16 CUP, UNIT-DOSE in 1 CARTON > 15 mL in 1 CUP, UNIT-DOSE | 6 carton | 2019-12-03 | 0000-00-00 | No | No | Current |
| 0121-0873-08 | 00121087308 | 237 mL in 1 BOTTLE (0121-0873-08) | 237 ml | 2019-12-03 | 0000-00-00 | No | No | Current |
| 0121-0873-15 | 00121087315 | 15 mL in 1 CUP, UNIT-DOSE (0121-0873-15) | 15 ml | 2019-12-03 | | No | No | Historical |
| 0121-0873-16 | 00121087316 | 473 mL in 1 BOTTLE (0121-0873-16) | 473 ml | 2019-12-03 | 0000-00-00 | No | No | Current |
| 0121-0873-32 | 00121087332 | 946 mL in 1 BOTTLE (0121-0873-32) | 946 ml | 2019-12-03 | 0000-00-00 | No | No | Current |
| 0121-0873-40 | 00121087340 | 4 TRAY in 1 CASE (0121-0873-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-0873-15) | 4 tray | 2019-12-03 | 0000-00-00 | No | No | Current |