What is NDC 0009-0436?

0009-0436 is the product NDC for R-Gene (arginine hydrochloride), Arginine hydrochloride 10 g/100mL injection, solution, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

R-Gene (Arginine Hydrochloride).

Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for R-Gene?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

R-Gene NDC 0009-0436 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0009-0436Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00009-0436Add 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
0009-0436-01	00009043601	1 CONTAINER in 1 CARTON (0009-0436-01) / 300 mL in 1 CONTAINERMarketed from Jun 15, 1976

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): R-Gene
Generic name (nonproprietary): arginine hydrochloride
Active ingredients: Arginine hydrochloride — 10 g/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Pharmacia & Upjohn Company LLCNDC labeler code 0009
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016931
Marketing start: Jun 15, 1976
Listing expires: Dec 31, 2026
Identifiers: Product ID 0009-0436_92dc2b43-3599-4859-b08b-29c024171f08SPL ID 92dc2b43-3599-4859-b08b-29c024171f08SPL set ID 6accf33f-9841-4327-8923-93c42020ef12UNII F7LTH1E20Y

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400009043601 followed by a unit qualifier and the quantity

Package 00009-0436-01. 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 Apr 2, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE R-Gene ® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature. If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene ® 10 is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0009-0436

What is NDC 0009-0436?: 0009-0436 is the product NDC for R-Gene (arginine hydrochloride), Arginine hydrochloride 10 g/100mL injection, solution, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: R-Gene (Arginine Hydrochloride).
What is the active ingredient?: Arginine hydrochloride.
Who is the labeler?: Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for R-Gene?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

R-Gene (Arginine hydrochloride) NDC 0009-0436