NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9092Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9092Add 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 NDC11-digit (billing)PackageCopy
0143-9092-0100143909201001439092011 VIAL in 1 BOX (0143-9092-01) / 5 mL in 1 VIALMarketed from Jan 19, 2018

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)
Doxorubicin Hydrochloride
Generic name (nonproprietary)
doxorubicin hydrochloride
Active ingredients
Doxorubicin hydrochloride — 2 mg/mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062921
Marketing start
Listing expires
Other FDA classes
Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers
Product ID 0143-9092_3b0d5f19-5eab-4729-8fbf-3b988cbc6d04SPL ID 3b0d5f19-5eab-4729-8fbf-3b988cbc6d04SPL set ID f62aa88d-1e25-4049-87ec-99d42edd1d31RxCUI 1790095, 1790103UNII 82F2G7BL4E
Pharmacologic class
Anthracycline Topoisomerase Inhibitor

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

N400143909201 followed by a unit qualifier and the quantity

Package 00143-9092-01. 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)

Doxorubicin is an anthracycline topoisomerase II inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1) . for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2) . 1.1 Adjuvant Breast Cancer DOX…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9092

What is NDC 0143-9092?
0143-9092 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Doxorubicin Hydrochloride.
What is the active ingredient?
Doxorubicin hydrochloride.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxorubicin Hydrochloride?
54 other product NDCs are listed under this name. See all Doxorubicin Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Doxorubicin Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousBluePoint Laboratories68001-70668001-0706-36
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousBluePoint Laboratories68001-70768001-0707-26
Doxorubicin HydrochlorideDoxorubicin hydrochloride 2 mg/mLInjectable, LiposomalIntravenousBluePoint Laboratories68001-70368001-0703-36
Doxorubicin HydrochlorideDoxorubicin hydrochloride 2 mg/mLInjectable, LiposomalIntravenousBluePoint Laboratories68001-70468001-0704-26
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousAlembic Pharmaceuticals Limited46708-52546708-0525-25
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousAlembic Pharmaceuticals Limited46708-81046708-0810-10
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousAlembic Pharmaceuticals Inc.62332-52562332-0525-25
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousAlembic Pharmaceuticals Inc.62332-81062332-0810-10
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousDr. Reddy's Laboratories Inc.75907-36375907-0363-01
doxorubicin hydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Suspension, LiposomalIntravenousDr. Reddy's Laboratories Inc.75907-36475907-0364-01

All 55 Doxorubicin Hydrochloride NDCs

Other NDCs under ANDA 062921

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

FDA NDC Directory listings under ANDA 062921
ProductStrengthForm · routeLabelerProduct NDC
Doxorubicin HydrochlorideDoxorubicin hydrochloride 2 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-9093

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