Betaine Anhydrous
- Product NDC
- 71863-115
- 11-digit product format
- 718630115
- Labeler code
- 71863
- Product ID
- 71863-115_42c7a42b-6a75-69d3-e063-6294a90acc18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betaine Anhydrous
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Eton Pharmaceuticals, Inc.
- Application
- ANDA210508
- Marketing category
- ANDA
- Marketing start
- 2022-01-28
- Substance
- BETAINE
- Active strength
- 1 g/g
- Pharmacologic classes
- Methylating Activity [MoA], Methylating Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Betaine Anhydrous
- Listing expiration
- 2026-12-31
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 |
|---|
| 71863-115-18 | Betaine Anhydrous | 180 g in 1 BOTTLE | POWDER, FOR SOLUTION | 180 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71863-115 | BETAINE ANHYDROUS POWDER, FOR SOLUTION [ETON PHARMACEUTICALS, INC.] | 6 | Current NDC, 1 package rows | 20241025_ee8a95c3-df9f-6e55-e053-2a95a90ab17b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71863-115-18 | 71863011518 | 180 g in 1 BOTTLE (71863-115-18) | 180 g | 2022-01-28 | No | No | Current |