Betaine Anhydrous For Oral Solution
- Product NDC
- 55792-002
- 11-digit product format
- 557920002
- Labeler code
- 55792
- Product ID
- 55792-002_30e4146a-b2bd-4dd3-9495-ff03c84b0c94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- betaine
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Lukare Medical, LLC
- Application
- ANDA210508
- Marketing category
- ANDA
- Marketing start
- 2022-02-11
- Marketing end
- 0000-00-00
- Substance
- BETAINE
- Active strength
- 1 g/g
- Pharmacologic classes
- Methylating Activity [MoA], Methylating Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 55792-002-01 | Betaine Anhydrous For Oral Solution | 180 g in 1 BOTTLE | POWDER, FOR SOLUTION | 180 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55792-002 | BETAINE ANHYDROUS FOR ORAL SOLUTION (BETAINE) POWDER, FOR SOLUTION [LUKARE MEDICAL, LLC] | 3 | Legacy NDC, 1 package rows | 20220212_ef44452a-5707-0d39-cbba-2fa285fb994c.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 |
|---|
| 55792-002-01 | 55792000201 | 180 g in 1 BOTTLE (55792-002-01) | 180 g | 2022-02-11 | 0000-00-00 | No | No | Current |