NDC 0245-0271
Oxandrolone
Oxandrolone
Oxandrolone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Oxandrolone.
| Product ID | 0245-0271_24672ff6-88f0-4cb5-95c0-12d9907534f5 |
| NDC | 0245-0271 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Oxandrolone |
| Generic Name | Oxandrolone |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2006-12-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076761 |
| Labeler Name | Upsher-Smith Laboratories, LLC |
| Substance Name | OXANDROLONE |
| Active Ingredient Strength | 3 mg/1 |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0245-0271-01
100 BLISTER PACK in 1 BOX, UNIT-DOSE (0245-0271-01) > 1 TABLET in 1 BLISTER PACK (0245-0271-89)
| Marketing Start Date | 2006-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0245-0271-01 [00245027101]
Oxandrolone TABLET
| Marketing Category | ANDA |
| Application Number | ANDA076761 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-12-01 |
NDC 0245-0271-89 [00245027189]
Oxandrolone TABLET
| Marketing Category | ANDA |
| Application Number | ANDA076761 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-12-01 |
NDC 0245-0271-10 [00245027110]
Oxandrolone TABLET
| Marketing Category | ANDA |
| Application Number | ANDA076761 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-12-01 |
NDC 0245-0271-11 [00245027111]
Oxandrolone TABLET
| Marketing Category | ANDA |
| Application Number | ANDA076761 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2006-12-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| OXANDROLONE | 2.5 mg/1 |
OpenFDA Data
| SPL SET ID: | b4ba1f43-5628-4e79-a4aa-f5c466cb517a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "Oxandrolone" or generic name "Oxandrolone"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0245-0271 | Oxandrolone | Oxandrolone |
| 0245-0272 | oxandrolone | oxandrolone |
| 49884-301 | Oxandrolone | oxandrolone |
| 49884-302 | Oxandrolone | oxandrolone |
| 63629-7603 | Oxandrolone | oxandrolone |
| 68084-424 | Oxandrolone | oxandrolone |
| 68084-425 | Oxandrolone | oxandrolone |
Trademark Results [Oxandrolone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXANDROLONE 85354270 4126968 Live/Registered |
PBB TRADEMARK HOLDINGS, LLC 2011-06-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.