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R-Gene Arginine Hydrochloride 10 g/100mL Injection, Solution, 300 mL — NDC 00009-0436-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

R-Gene Arginine Hydrochloride 10 g/100mL Injection, Solution, 300 mL — NDC 0009-0436-01 (Billing 00009-0436-01)

by Pharmacia & Upjohn Company LLC · 1 CONTAINER in 1 CARTON / 300 mL in 1 CONTAINER

This is a package of 300 mL of R-Gene Arginine Hydrochloride 10 g/100mL Injection, Solution from Pharmacia & Upjohn Company LLC, marketed since Jun 1976 and currently FDA-listed. It is this product's only package size.

NDC 00009-0436-01
🏷️ FDA NDC (as labeled) 0009-0436-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0009-0436-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0009 labeler · 0436 product · 01 package
Package marketed since
Jun 15, 1976
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
300 mL per package
Barcode (UPC-A, from the NDC)
3 0009043601 8
Medicaid fills, this package
161 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0009-0436-01
Product NDC 0009-0436
11-digit billing NDC 00009043601
NCPDP billing unit ML — per mL (volume)
UNII F7LTH1E20Y
Application # NDA016931
SPL Set ID 6accf33f-9841-4327-8923-93c42020ef12
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1976-06-15
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ARGININE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 94200012102005
GPI class R-Gene 10
GCN Seq No 037018
GCN 57881
HICL code 010305
Ingredient (HICL) Arginine Hcl
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1U
Therapeutic class — specific (HIC3) Metabolic Function Diagnostics
AHFS code 36:66.00.00
AHFS class Pituitary Function
FDB label name R-GENE 10 VIAL
FDB brand name R-Gene 10
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 037018
  • GCN: 57881
  • GPI-14 (Medi-Span): 94200012102005
  • HICL (First Databank): 010305
  • AHFS class code: 36:66.00.00
Why two NDCs? The FDA registers this code as 0009-0436-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00009-0436-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name R-GENE 10 VIAL Ingredient Arginine Hcl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.1870 $56.10 / 300 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00009-0436-01 You're viewing this Main listing 1 CONTAINER in 1 CARTON / 300 mL in 1 CONTAINER 1976-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
R-Gene 10 g/100mLthis 00009-0436-01 Pharmacia 300 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1976
On the market since
Jun 1976
📍
2026
Currently FDA-listed
50 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPharmacia & Upjohn Company LLC
Application holderPHARMACIA AND UPJOHN CO
FDA applicationNDA016931 (NDA)
Labeler code00009
First marketedJun 1976
Product typeHuman Prescription Drug
Portfolio106 products on file

More NDCs from Pharmacia & Upjohn Company LLC labeler code 00009

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 185 words ▾

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 not respond to R-Gene ® 10 (Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day.

Some patients who respond to R-Gene ® 10 do not respond to insulin and vice versa. The rate of false positive responses for R-Gene ® 10 is approximately 32%, and the rate of false negatives is approximately 27%.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Adult Dosage The recommended adult dose is 30 g arginine hydrochloride (300 mL of R-Gene ® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride. See Directions for Use for preparation instructions.

Pediatric Dosage The recommended pediatric dose is 0.5 g/kg arginine hydrochloride (5 mL/kg of R-Gene ® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride. • For patients weighing 59 kg or less , withdraw a weight based dose from a sealed R-Gene ® 10 bottle and place in a separate container for intravenous infusion to avoid the inadvertent delivery and administration of the total volume from the commercially available container. See Directions for Use for preparation instructions. • For patients weighing 60 kg or more , the recommended dose is 30 g arginine hydrochloride (300 mL of R-Gene ® 10).

See Directions for Use for preparation instructions Test Procedure The intravenous infusion of R-Gene ® 10 is a part of the test for measurement of pituitary reserve of human growth hormone and, for successful administration of the test, clinical conditions and procedures should be as follows: 1. The test should be scheduled in the morning following a normal night's sleep, and an overnight fast should continue through the test period. 2.

Patients must be placed at bed rest for at least 30 minutes before the infusion begins. Care should be taken to minimize apprehension and distress. This is particularly important in children.

3. R-Gene ® 10 (Arginine Hydrochloride Injection, USP) is a hypertonic solution and should only be infused through an indwelling needle or soft catheter placed in an antecubital vein or other suitable vein (see PRECAUTIONS ). Blood samples should be taken by venipuncture from the contra-lateral arm.

4. A desirable schedule for drawing blood samples is at −30, 0, 30, 60, 90, 120 and 150 minutes. 5.

R-Gene ® 10 should be infused beginning at zero time at a uniform rate which will permit the recommended dose to be administered over 30 minutes. 6. Blood samples should be promptly centrifuged and the plasma stored at −20°C until assayed by one of the published radioimmunoassay procedures.

7. Diagnostic test results showing a deficiency of pituitary reserve for HGH should be confirmed by a second test with R-Gene ® 10, or one may elect to confirm with the insulin hypoglycemia test. A waiting period of one day is advised between tests.

Directions for Use R-Gene ® 10 is provided as a ready-to-use solution for patients weighing 60 kg (132 lbs) or more and should not be further diluted. For pediatric patients weighing 59 kg (130 lbs) or less a dose must be placed in a separate container. Follow the preparation instructions below.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. For Pediatric Patients weighing 59 kg (130 lbs) or less: Withdraw a weight-based dose from an intact sealed bottle of R-Gene ® 10. The entire 300 mL bottle of R-Gene ® 10 for infusion is not intended for use in patients weighing 59 kg or less.

The dose must be placed in a separate container, such as an evacuated sterile glass container designed for intravenous administration, using aseptic technique. Additionally, R-Gene ® 10 is stable in polypropylene syringes and plastic containers made of either polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA). The post-penetration storage period is not more than 4 hours including infusion time at room temperature or 24 hours at refrigerated temperature (2-8°C).

The healthcare professional administering the dose should verify the accuracy of the dose prior to administration. Use only if the solution is clear. Discard any unused drug product.

For Adults and Pediatric Patients weighing 60kg (132 lbs) or more: Follow these directions using aseptic te… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS The administration of R-Gene ® 10 is contraindicated in persons having known hypersensitivity to any ingredient in this product.

⚠️ Warnings 114 words ▾

WARNINGS There have been reports of overdosage of R-Gene ® 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE ® 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE ® 10 IN PEDIATRIC PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS, CEREBRAL EDEMA, OR POSSIBLY DEATH.

Hypersensitivity reactions, including anaphylaxis have been reported. Appropriate medical support should be available during R-Gene ® 10 administration. If anaphylaxis or other serious hypersensitivity reaction occurs, R-Gene ® 10 should be discontinued and appropriate medical treatment initiated.

R-Gene ® 10 should always be administered by intravenous infusion because of its hypertonicity. R-Gene ® 10 is a diagnostic aid and is not intended for therapeutic use.

🤒 Adverse Reactions 181 words ▾

ADVERSE REACTIONS Adverse reactions associated with 1670 infusions in premarketing studies were as follows: Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients. One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered.

One patient had an apparent decrease in platelet count from 150,000 to 60,000. One patient with a history of acrocyanosis had an exacerbation of this condition following infusion of R-Gene ® 10. Post Marketing Experience: The following adverse events have been reported during post-marketing use: extravasation leading to burn-like reaction and/or skin necrosis requiring surgical intervention, hypersensitivity reactions including anaphylaxis, and hematuria that in some cases occurred 1–2 days after an R-Gene ® 10 administration.

Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

🤰 Pregnancy 78 words ▾

Pregnancy Reproduction studies have been performed in rabbits and mice at doses 12 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to R-Gene ® 10 (10% Arginine Hydrochloride Injection, USP). There have been no adequate or well controlled studies for the use of R-Gene ® 10 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.

🧓 Geriatric Use 43 words ▾

Geriatric Use Clinical studies of arginine did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 59 words ▾

OVERDOSAGE An overdosage may cause a transient metabolic acidosis with hyperventilation, which could lead to death (see " WARNINGS "). In most cases the acidosis will self-compensate and the base deficit will return to normal following completion of the infusion. If the condition persists, the deficit should be determined and corrected by a calculated dose of an alkalizing agent.

🧬 Clinical Pharmacology 131 words ▾

CLINICAL PHARMACOLOGY Intravenous infusion of R-Gene ® 10 often induces a pronounced rise in the plasma level of human growth hormone (HGH) in subjects with intact pituitary function. This rise is usually diminished or absent in patients with impairment of this function. Expected Plasma Levels of HGH in ng/mL Patient Control Range Range of Peak Response to Arginine Normal 0–6 10–30 Pituitary deficient 0–4 0–10 These ranges are based on the mean values of plasma HGH levels calculated from the data of several clinical investigators and reflect their experiences with various methods of radioimmunoassay.

Upon gaining experience with this diagnostic test, each clinician will establish his/her own ranges for control and peak levels of HGH. L-arginine is a normal metabolite in animals and man and has a low order of toxicity.

📦 How Supplied / Storage and Handling 78 words ▾

HOW SUPPLIED R-Gene ® 10 is supplied as a 30 g/300 mL (0.1 g/mL) fill in 500 mL glass containers. Preservative Free: Discard any unused portion. NDC 0009-0436-01 Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Solution that has been frozen must not be used.

LAB-0020-13.0 Revised Aug 2023 Logo

📋 Description 73 words ▾

DESCRIPTION Each 100 mL of R-Gene ® 10 (Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP (equivalent to a 10% solution) (0.1 g/mL). L-arginine is a naturally occurring amino acid. R-Gene ® 10 is hypertonic (950 mOsmol/liter) and contains 47.5 mEq of chloride ion per 100 mL of solution. The pH is adjusted to 5.6 (5.0–6.5) with arginine base or hydrochloric acid.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General R-Gene ® 10 is a hypertonic (950 mOsmol/liter) and acidic (average pH of 5.6) solution that can cause irritation and damage to tissues. Care should be used to ensure administration of R-Gene ® 10 through a patent catheter within a patent vein. Excessive rates of infusion may result in local irritation and in flushing, nausea, or vomiting.

Inadequate dosing or prolongation of the infusion period may diminish the stimulus to the pituitary and nullify the test. The arginine in R-Gene ® 10 can be metabolized resulting in nitrogen-containing products for excretion. The effect of an acute amino acid or nitrogen burden upon patients with impairment of renal function should be considered when R-Gene ® 10 is to be administered.

The chloride content of R-Gene ® 10 is 47.5 mEq per 100 mL of solution, and the effect of infusing this amount of chloride into patients with electrolyte imbalance should be evaluated before the test is undertaken. It should be noted that the basal and post stimulation levels of growth hormone are elevated in patients who are pregnant or are taking oral contraceptives. Carcinogenesis, mutagenesis, and impairment of fertility Long term animal studies have not been performed to evaluate the carcinogenic potential, the mutagenic potential or the effect on fertility of intravenously administered R-Gene ® 10.

Pregnancy Reproduction studies have been performed in rabbits and mice at doses 12 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to R-Gene ® 10 (10% Arginine Hydrochloride Injection, USP). There have been no adequate or well controlled studies for the use of R-Gene ® 10 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.

Nursing Mothers It is not known whether intravenous administration of R-Gene ® 10 could result in significant quantities of arginine in breast milk. Systemically administered amino acids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when R-Gene ® 10 is to be administered to nursing women.

Geriatric Use Clinical studies of arginine did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🍼 Nursing Mothers 60 words ▾

Nursing Mothers It is not known whether intravenous administration of R-Gene ® 10 could result in significant quantities of arginine in breast milk. Systemically administered amino acids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when R-Gene ® 10 is to be administered to nursing women.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 33 words ▾

Carcinogenesis, mutagenesis, and impairment of fertility Long term animal studies have not been performed to evaluate the carcinogenic potential, the mutagenic potential or the effect on fertility of intravenously administered R-Gene ® 10.

📄 Package Label / Principal Display Panel 140 words ▾

PRINCIPAL DISPLAY PANEL - 300 mL Container Label NDC 0009-0436-01 Rx only 300 mL Single Adult Dose Container. R-Gene ® 10 (Arginine Hydrochloride Injection, USP) For Intravenous Use 30 g/300 mL (0.1 g/mL) Pfizer Distributed by Pharmacia & Upjohn Company LLC A subsidiary of Pfizer Inc. New York, NY 10001 PRINCIPAL DISPLAY PANEL - 300 mL Container Label

PRINCIPAL DISPLAY PANEL - 300 mL Container Carton NDC 0009-0436-01 300 mL Single Adult Dose Container. R-Gene ® 10 (Arginine Hydrochloride Injection, USP) For Intravenous Use 30 g/300 mL (0.1 g/mL) Warning: Do not use this container to administer a dose to children weighing 59 kg (130 lbs) or less. A weight based dose must be withdrawn and placed into a separate container for intravenous administration.

See the Directions of Use subsection. Rx only PRINCIPAL DISPLAY PANEL - 300 mL Container Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
161
Units reimbursed last 4 qtrs
48.2K
Gross reimbursed last 4 qtrs
$9K
Avg / prescription
$56.00
Avg / unit
$0.1870
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
16% FFS 84% MCO
Fee-for-service · 25 Rx Managed care · 136 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 16,200 units · 125 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 28 units · 0.4 per 100k residents MA California: 31,942 units · 82.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 52 units · 1.1 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.4125
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 125 /100k
2 California 82.0 /100k
3 Kentucky 1.1 /100k
4 Massachusetts 0.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pharmacia & Upjohn Company LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmacia & Upjohn Company LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00009-0420-01 · Pharmacia 00009-0450-03 · Pharmacia →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.