Testosterone
- Product NDC
- 68180-941
- 11-digit product format
- 681800941
- Labeler code
- 68180
- Product ID
- 68180-941_b49d821a-a323-42d4-912a-7c673e813b36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA208560
- Marketing category
- ANDA
- Marketing start
- 2019-04-10
- Substance
- TESTOSTERONE
- Active strength
- 16.2 mg/g
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Testosterone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 16.2 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1597076 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-941-11 | Testosterone | 88 g in 1 BOTTLE, PUMP | GEL | 88 | | 10 |
| 68180-941-11 | Testosterone | 1 in 1 CARTON | GEL | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-941 | TESTOSTERONE GEL [LUPIN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250309_61387416-510d-40c5-9e2d-24bfb7f56d08.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 |
|---|
| 68180-941-11 | 68180094111 | 1 BOTTLE, PUMP in 1 CARTON (68180-941-11) / 88 g in 1 BOTTLE, PUMP | 2019-04-10 | 0000-00-00 | No | No | Current |