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NDC 75854-0602-02 Balcoltra Details
Balcoltra
Balcoltra is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals. The primary component is .
Product Information
| NDC | 75854-0602 |
|---|---|
| Product ID | 75854-602_0ca934cf-a654-435c-ad1e-73fd7c563318 |
| Associated GPIs | 25990003350320 |
| GCN Sequence Number | 078077 |
| GCN Sequence Number Description | levonorgest/eth.estradiol/iron TABLET 0.1-0.02MG ORAL |
| HIC3 | G8A |
| HIC3 Description | CONTRACEPTIVES,ORAL |
| GCN | 44336 |
| HICL Sequence Number | 044733 |
| HICL Sequence Number Description | LEVONORGESTREL/ETHINYL ESTRADIOL/IRON |
| Brand/Generic | Brand |
| Proprietary Name | Balcoltra |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levonorgestrel and ethinyl estradiol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Avion Pharmaceuticals |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208612 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75854-0602-02 (75854060202)
| NDC Package Code | 75854-602-02 |
|---|---|
| Billing NDC | 75854060202 |
| Package | 2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK |
| Marketing Start Date | 2018-04-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |