Cystadane
- Product NDC
- 52276-400
- 11-digit product format
- 522760400
- Labeler code
- 52276
- Product ID
- 52276-400_3a4fdd66-b72b-4aa3-94bb-bac8af98b150
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- betaine
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Recordati Rare Diseases
- Application
- NDA020576
- Marketing category
- NDA
- Marketing start
- 1996-10-25
- 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
- Cystadane
- 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 | 404539, 562847 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52276-400-01 | Cystadane | 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 |
|---|
| 52276-400 | CYSTADANE (BETAINE) POWDER, FOR SOLUTION [RECORDATI RARE DISEASES] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230112_31a684d0-cd98-4e46-b43a-ccbd17c41559.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 |
|---|
| 52276-400-01 | 52276040001 | 180 g in 1 BOTTLE (52276-400-01) | 180 g | 2017-04-13 | 0000-00-00 | No | No | Current |