Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
- Product NDC
- 43386-030
- 11-digit product format
- 433860030
- Labeler code
- 43386
- Product ID
- 43386-030_a1083256-d69a-4ff6-be4e-9719451792ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA079247
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Substance
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- Active strength
- .398; 1.105 g/1; g/1
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | .398 g/1 |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 1.105 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 22ADO53M6F, 593YOG76RN |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-030-01 | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-030 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET [LUPIN PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240131_e2fcc382-6fac-4438-ad02-ebc8528dd59a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43386-030-01 | 43386003001 | 100 TABLET in 1 BOTTLE (43386-030-01) | 100 tablet | 2012-01-20 | 0000-00-00 | No | No | Current |