Prescription drug · ANDA
Testosterone NDC 64380-151
Testosterone 25 mg/2.5g · Gel · Transdermal · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-151-02 | 6438001510264380015102 | 30 DOSE PACK in 1 CARTON (64380-151-02) / 2.5 g in 1 DOSE PACK (64380-151-01)Marketed from Jun 27, 2022 |
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 — 25 mg/2.5g
- Dosage form
- Gel
- Route
- Transdermal
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076744
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 64380-151_6d50f17e-4607-458a-882b-620daa3b58a9SPL ID 6d50f17e-4607-458a-882b-620daa3b58a9SPL set ID ee54c393-bcfe-4a52-b7b3-1da8750f35d9RxCUI 1597123, 1597129UNII 3XMK78S47OUPC 0364380151012, 0364380152019
- 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
N464380015102followed by a unit qualifier and the quantityPackage 64380-0151-02. 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% 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 (LHRH) d…
Excerpt only. Read the full label for complete information.
About NDC 64380-151
- What is NDC 64380-151?
- 64380-151 is the product NDC for Testosterone, Testosterone 25 mg/2.5g gel, listed with the FDA by Strides Pharma Science Limited. 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?
- Strides Pharma Science Limited, NDC labeler code 64380. 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 20.25 mg/1.25g | Gel, MeteredTransdermal | Northstar Rx LLC | 72603-265 | 72603-0265-01 |
| Testosterone | Testosterone 50 mg/5g | GelTransdermal | Strides Pharma Science Limited | 64380-152 | 64380-0152-02 |
Other NDCs under ANDA 076744
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 50 mg/5g | GelTransdermal | Strides Pharma Science Limited | 64380-152 |