Leonurus Cardiaca
- Product NDC
- 53645-1270
- 11-digit product format
- 536451270
- Labeler code
- 53645
- Product ID
- 53645-1270_ba25c0de-7d73-c1c4-e053-2a95a90a90fa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Leonurus Cardiaca
- Dosage form
- GLOBULE
- Route
- ORAL
- Labeler
- True Botanica, LLC
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2013-06-20
- Marketing end
- 0000-00-00
- Substance
- LEONURUS CARDIACA
- Active strength
- 6 [hp_X]/23g
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53645-1270 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 53645-1270 | 53645-1270-2 | D | Discontinued by firm | 2026-08-11 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53645-1270-2 | 2021-01-31 | C162847 | 48780-1 | ba0f9c33-3ed3-a910-e053-dadaa90a0b85 | Leonurus Cardiaca 6x |
| 53645-1270-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3ed3-a910-e053-dadaa90a0b85 | Leonurus Cardiaca 6x |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEONURUS CARDIACA | ACTIVE INGREDIENT | 8NC0C2YXK0 | LEONURUS CARDIACA GLOBULE [TRUE BOTANICA, LLC] | 1 | |
| LEONURUS CARDIACA | ACTIVE MOIETY | 8NC0C2YXK0 | LEONURUS CARDIACA GLOBULE [TRUE BOTANICA, LLC] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | LEONURUS CARDIACA GLOBULE [TRUE BOTANICA, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53645-1270 | LEONURUS CARDIACA GLOBULE [TRUE BOTANICA, LLC] | 3 | Legacy NDC | 20210131_35f583dc-fc26-40a1-8a24-30ac531bf407.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53645-1270-2 | 53645127002 | 23 g in 1 BOTTLE (53645-1270-2) | 23 g | 2013-06-20 | 0000-00-00 | No | No | Current |