Testosterone
- Product NDC
- 68180-943
- 11-digit product format
- 681800943
- Labeler code
- 68180
- Product ID
- 68180-943_0ed3a7bc-bbb1-4cc3-9d09-b09c0c4e8892
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA208061
- Marketing category
- ANDA
- Marketing start
- 2018-02-23
- Substance
- TESTOSTERONE
- Active strength
- 30 mg/1.5mL
- 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 | 30 mg/1.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1599949 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-943-11 | Testosterone | 90 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 90 | | 13 |
| 68180-943-11 | Testosterone | 1 in 1 CARTON | SOLUTION | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-943 | TESTOSTERONE SOLUTION [LUPIN PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250316_29c8846f-121c-4958-9e03-3bd271c21558.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 |
|---|
| 68180-943-11 | 68180094311 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68180-943-11) / 90 mL in 1 BOTTLE, WITH APPLICATOR | 2018-02-23 | 0000-00-00 | No | No | Current |