Testosterone
- Product NDC
- 0832-1121
- 11-digit product format
- 008321121
- Labeler code
- 0832
- Product ID
- 0832-1121_39853cd7-bfd1-848f-e063-6294a90a49e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL, METERED
- Route
- TOPICAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- NDA204399
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-06-16
- Substance
- TESTOSTERONE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Testosterone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1596780, 1597129 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-1121-40 | Testosterone | 60 in 1 BOTTLE, PUMP | GEL, METERED | 60 | | 13 |
| 0832-1121-42 | Testosterone | 2 in 1 CARTON | GEL, METERED | 2 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Testosterone | ACTIVE INGREDIENT | 3XMK78S47O | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| Testosterone | ACTIVE MOIETY | 3XMK78S47O | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | INACTIVE INGREDIENT | 809Y72KV36 | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) | INACTIVE INGREDIENT | 4Q93RCW27E | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| diisopropyl adipate | INACTIVE INGREDIENT | P7E6YFV72X | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| methyl laurate | INACTIVE INGREDIENT | 8IPS6BI6KW | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| oleyl alcohol | INACTIVE INGREDIENT | 172F2WN8DV | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| tromethamine | INACTIVE INGREDIENT | 023C2WHX2V | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-1121 | TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20230517_a887020f-b41f-49fe-8379-f01147b2a796.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0832-1121-40 | 00832112140 | 60 in 1 BOTTLE, PUMP | | | | | Historical |
| 0832-1121-42 | 00832112142 | 2 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40) | 2014-06-16 | 0000-00-00 | No | No | Current |