NDC 63629-8816-01 - Glatopa
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 63629-8816
- Requested NDC
- 63629-8816-01
- Package NDCs from labels
- 63629-8816-1, 63629-8816-01
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2025-03-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Glatopa - Bryant Ranch Prepack | Bryant Ranch Prepack | 2025-03-27 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-8816-1 | Glatopa | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | 103 | |
| 63629-8816-1 | Glatopa | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | 103 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-8816 | GLATOPA (GLATIRAMER ACETATE) INJECTION, SOLUTION [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 2 package rows | 20250330_028fdf0e-2340-407b-bcd8-5a99accdddbf.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8816-1 | ML - Milliliter | 63629-8816 | 16f03e83-bcf2-437a-93a8-18e4fc43151e | 1 | 2021-12-08 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.