BIOTENE
- Product NDC
- 0135-0487
- 11-digit product format
- 001350487
- Labeler code
- 0135
- Product ID
- 0135-0487_907b0d6b-e1d2-431e-82cf-9be27f8ac1d7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium monofluorophosphate
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-04-18
- Marketing end
- 0000-00-00
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0135-0487-01 | 2022-01-07 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-02 | 2022-01-07 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-01 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-02 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-01 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-02 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
| 0135-0487-02 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33a0-f274-e053-dbdaa90a6471 | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0487-01 | GM - Gram | 0135-0487 | 14ac07c7-a7fc-4ec5-9114-4c4bde615c4a | 1 | 2013-12-02 |
| 0135-0487-02 | GM - Gram | 0135-0487 | d955ad3b-dd17-493c-a2fc-dffbd82aac8c | 1 | 2013-12-02 |