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NDC 00430-0979-03 Atelvia 30.1; 4.9 mg/1; mg/1 Details
Atelvia 30.1; 4.9 mg/1; mg/1
Atelvia is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE.
Product Information
| NDC | 00430-0979 |
|---|---|
| Product ID | 0430-0979_b02fe687-a8b8-43c1-84d3-b9a35f6b0043 |
| Associated GPIs | 30042065100635 |
| GCN Sequence Number | 066815 |
| GCN Sequence Number Description | risedronate sodium TABLET DR 35 MG ORAL |
| HIC3 | P4L |
| HIC3 Description | BONE RESORPTION INHIBITORS |
| GCN | 29223 |
| HICL Sequence Number | 018565 |
| HICL Sequence Number Description | RISEDRONATE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | Atelvia |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | risedronate sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 30.1; 4.9 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE |
| Labeler Name | Allergan, Inc. |
| Pharmaceutical Class | Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022560 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00430-0979-03 (00430097903)
| NDC Package Code | 0430-0979-03 |
|---|---|
| Billing NDC | 00430097903 |
| Package | 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03) |
| Marketing Start Date | 2010-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |