Search by Drug Name or NDC
NDC 00259-1605-01 Xeomin 50 [USP'U]/1 Details
Xeomin 50 [USP'U]/1
Xeomin is a INTRAMUSCULAR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merz Pharmaceuticals, LLC. The primary component is BOTULINUM TOXIN TYPE A.
Product Information
| NDC | 00259-1605 |
|---|---|
| Product ID | 0259-1605_cebab8bd-7c0c-4a2f-bf9b-56feadb6dcc8 |
| Associated GPIs | 74400020202120 |
| GCN Sequence Number | 066629 |
| GCN Sequence Number Description | incobotulinumtoxinA VIAL 50 UNIT INTRAMUSC |
| HIC3 | S7A |
| HIC3 Description | NEUROMUSCULAR BLOCKING AGENTS |
| GCN | 28953 |
| HICL Sequence Number | 036687 |
| HICL Sequence Number Description | INCOBOTULINUMTOXINA |
| Brand/Generic | Brand |
| Proprietary Name | Xeomin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | incobotulinumtoxinA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | [USP'U]/1 |
| Substance Name | BOTULINUM TOXIN TYPE A |
| Labeler Name | Merz Pharmaceuticals, LLC |
| Pharmaceutical Class | Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125360 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00259-1605-01 (00259160501)
| NDC Package Code | 0259-1605-01 |
|---|---|
| Billing NDC | 00259160501 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (0259-1605-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2010-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |