Testosterone NDC 43598-304

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-304Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0304Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43598-304-88	43598030488	1 BOTTLE, PUMP in 1 CARTON (43598-304-88) / 88 g in 1 BOTTLE, PUMPMarketed from Apr 12, 2019

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 — 1.62 mg/g
Dosage form: Gel, Metered
Route: Transdermal
Labeler: Dr. Reddy's Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208620
Marketing start: Apr 12, 2019
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 43598-304_e1612112-46cf-11c4-9e02-9178073b50abSPL ID e1612112-46cf-11c4-9e02-9178073b50abSPL set ID ccadef00-3d5f-f926-e0fb-8dabe859f271UNII 3XMK78S47O
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

N443598030488 followed by a unit qualifier and the quantity

Package 43598-0304-88. 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 May 21, 2019. 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 (LHRH…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208620

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208620
Product	Strength	Form · route	Labeler	Product NDC
Testosterone	Testosterone 16.2 mg/g	GelTransdermal	Encube Ethicals, Inc.	21922-030