Betaine
- Product NDC
- 0713-0352
- 11-digit product format
- 007130352
- Labeler code
- 0713
- Product ID
- 0713-0352_0863970c-af47-44c7-8418-65f17df50e68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betaine
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA214864
- Marketing category
- ANDA
- Marketing start
- 2023-01-01
- Substance
- BETAINE
- Active strength
- 1 g/g
- Pharmacologic classes
- Methylating Activity [MoA], Methylating Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Betaine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETAINE | 1 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3SCV180C9W |
| Rxcui | 562847 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0352-81 | Betaine | 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 |
|---|
| 0713-0352 | BETAINE POWDER, FOR SOLUTION [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221105_99b667fa-b00c-465b-bbed-36f317078115.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 |
|---|
| 0713-0352-81 | 00713035281 | 180 g in 1 BOTTLE (0713-0352-81) | 180 g | 2023-01-01 | 0000-00-00 | No | No | Current |