Glatopa
- Product NDC
- 63629-8816
- 11-digit product format
- 636298816
- Labeler code
- 63629
- Product ID
- 63629-8816_d1f6c590-1315-4499-9fcd-75ff92dcc5c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glatiramer Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206921
- Marketing category
- ANDA
- Marketing start
- 2018-02-12
- Substance
- GLATIRAMER ACETATE
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glatopa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLATIRAMER ACETATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M691HL4BO |
| Rxcui | 1487361, 2000007 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 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 |
|---|
| 63629-8816-1 | 63629881601 | 12 BLISTER PACK in 1 CARTON (63629-8816-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 12 blister pack | 2021-09-10 | 0000-00-00 | No | No | Current |