Prescription drug · ANDA
Testosterone NDC 72603-265
Testosterone 20.25 mg/1.25g · Gel, Metered · Transdermal · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-265-01 | 7260302650172603026501 | 1 BOTTLE, PUMP in 1 CARTON (72603-265-01) / 88 g in 1 BOTTLE, PUMPMarketed from Jan 24, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Testosterone
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 20.25 mg/1.25g
- Dosage form
- Gel, Metered
- Route
- Transdermal
- Labeler
- Northstar Rx LLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210835
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 72603-265_dafbd186-9750-83bc-351d-29ff1c1c0fa3SPL ID dafbd186-9750-83bc-351d-29ff1c1c0fa3SPL set ID 65981b8a-d5cc-1964-7eac-a07f032c2571RxCUI 1597076UNII 3XMK78S47OUPC 0372603265019
- Pharmacologic class
- Androgen
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472603026501followed by a unit qualifier and the quantityPackage 72603-0265-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Testosterone gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHR…
Excerpt only. Read the full label for complete information.
About NDC 72603-265
- What is NDC 72603-265?
- 72603-265 is the product NDC for Testosterone, Testosterone 20.25 mg/1.25g gel, metered, listed with the FDA by Northstar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Testosterone.
- What is the active ingredient?
- Testosterone.
- Who is the labeler?
- Northstar Rx LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Testosterone?
- 42 other product NDCs are listed under this name. See all Testosterone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Testosterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Testosterone | Testosterone 30 mg/1.5mL | SolutionTopical | Encube Ethicals, Inc. | 21922-109 | 21922-0109-16 |
| Testosterone | Testosterone 25 mg/2.5g | GelTransdermal | Prasco Laboratories | 66993-954 | 66993-0954-30 |
| Testosterone | Testosterone 16.2 mg/g | GelTransdermal | Prasco Laboratories | 66993-951 | 66993-0951-88 |
| Testosterone | Testosterone 16.2 mg/g | GelTransdermal | Prasco Laboratories | 66993-952 | 66993-0952-30 |
| Testosterone | Testosterone 12.5 mg/1.25g | GelTransdermal | Prasco Laboratories | 66993-953 | 66993-0953-44 |
| Testosterone | Testosterone 50 mg/5g | GelTransdermal | Prasco Laboratories | 66993-955 | 66993-0955-30 |
| Testosterone | Testosterone 30 [hp_X]/1 | TabletOral | Zoe Processing | 44117-0003 | 44117-0003-01 |
| Testosterone | Testosterone 16.2 mg/g | GelTransdermal | Encube Ethicals, Inc. | 21922-030 | 21922-0030-2021922-0030-52 |
| Testosterone | Testosterone 25 mg/2.5g | GelTransdermal | Strides Pharma Science Limited | 64380-151 | 64380-0151-02 |
| Testosterone | Testosterone 50 mg/5g | GelTransdermal | Strides Pharma Science Limited | 64380-152 | 64380-0152-02 |
Other NDCs under ANDA 210835
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Testosterone | Testosterone 20.25 mg/1.25g | Gel, MeteredTransdermal | Bryant Ranch Prepack | 63629-2352 |
| Testosterone | Testosterone 20.25 mg/1.25g | Gel, MeteredTransdermal | Xiromed, LLC | 70700-112 |
| Testosterone | Testosterone 20.25 mg/1.25g | Gel, MeteredTransdermal | Bryant Ranch Prepack | 72162-1962 |