What is NDC 0003-0315?

0003-0315 is the product NDC for Kenalog-80 (triamcinolone acetonide), Triamcinolone acetonide 80 mg/mL injection, suspension, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Kenalog-80 (Triamcinolone acetonide).

E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kenalog-80?

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.

Kenalog-80 NDC 0003-0315 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0003-0315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00003-0315Add 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
0003-0315-05	00003031505	1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0315-05) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 12, 2019
0003-0315-20	00003031520	1 VIAL, MULTI-DOSE in 1 CARTON (0003-0315-20) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 12, 2019

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): Kenalog-80
Generic name (nonproprietary): triamcinolone acetonide
Active ingredients: Triamcinolone acetonide — 80 mg/mL
Dosage form: Injection, Suspension
Route: Intra-articular, Intramuscular
Labeler: E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 014901
Marketing start: Apr 12, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0003-0315_721dbcb3-df3b-428c-a5e6-1c807025a14aSPL ID 721dbcb3-df3b-428c-a5e6-1c807025a14aSPL set ID cf970688-cd77-b95c-4bd9-c541590e9722RxCUI 1085754, 1085756, 1792144, 2168081, 2168083, 2168095, 2168097, 2480108UNII F446C597KA
Pharmacologic class: Corticosteroid

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

N400003031505 followed by a unit qualifier and the quantity

Package 00003-0315-05. 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 Aug 20, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including KENALOG-40 Injection and KENALOG-80 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Ste…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0003-0315

What is NDC 0003-0315?: 0003-0315 is the product NDC for Kenalog-80 (triamcinolone acetonide), Triamcinolone acetonide 80 mg/mL injection, suspension, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kenalog-80 (Triamcinolone acetonide).
What is the active ingredient?: Triamcinolone acetonide.
Who is the labeler?: E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kenalog-80?: 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.

Other NDCs under NDA 014901

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

FDA NDC Directory listings under NDA 014901
Product	Strength	Form · route	Labeler	Product NDC
Kenalog-40triamcinolone acetonide	Triamcinolone acetonide 40 mg/mL	Injection, SuspensionIntra-articular, Intramuscular	E.R. Squibb & Sons, L.L.C.	0003-0293
Kenalog-40triamcinolone acetonide	Triamcinolone acetonide 40 mg/mL	Injection, SuspensionIntra-articular, Intramuscular	Asclemed USA, Inc.	76420-085
Kenalog-40triamcinolone acetonide	Triamcinolone acetonide 40 mg/mL	Injection, SuspensionIntra-articular, Intramuscular	A-S Medication Solutions	50090-2360
Kenalog-40triamcinolone acetonide	Triamcinolone acetonide 40 mg/mL	Injection, SuspensionIntra-articular, Intramuscular	A-S Medication Solutions	50090-0256
Kenalog-40triamcinolone acetonide	Triamcinolone acetonide 40 mg/mL	Injection, SuspensionIntra-articular, Intramuscular	Proficient Rx LP	63187-661
Kenalog-40triamcinolone acetonide	Triamcinolone acetonide 40 mg/mL	Injection, SuspensionIntra-articular, Intramuscular	A-S Medication Solutions	50090-0819

Kenalog-80 (Triamcinolone acetonide) NDC 0003-0315