Risperidone
- Product NDC
- 64679-553
- 11-digit product format
- 646790553
- Labeler code
- 64679
- Product ID
- 64679-553_b3eefb63-0cd7-4733-b75a-1088cc99e115
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA078871
- Marketing category
- ANDA
- Marketing start
- 2008-10-09
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 0 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64679-553-01 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-02 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-03 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-04 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
| 64679-553-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6eaa-f424-e053-dadaa90a57ce | e812ad55-29ed-49b4-b81b-a789194de228 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64679-553-02 | EA - Each | 64679-553 | 23aa1f9f-261a-43a0-959e-b195302ed86e | 1 | 2012-07-24 |
| 64679-553-04 | EA - Each | 64679-553 | 47c52876-0bee-4d20-9475-4d06df0ca1bb | 1 | 2012-07-24 |