What is NDC 0338-9545?

0338-9545 is the product NDC for clindamycin phosphate, Clindamycin phosphate 300 mg/50mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.

Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for clindamycin phosphate?

70 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

clindamycin phosphate NDC 0338-9545

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9545Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9545Add 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
0338-9545-24	0033895452400338954524	24 BAG in 1 CARTON (0338-9545-24) / 50 mL in 1 BAG (0338-9545-50)Marketed from Apr 20, 2017

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): clindamycin phosphate
Generic name (nonproprietary): clindamycin phosphate
Active ingredients: Clindamycin phosphate — 300 mg/50mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Baxter Healthcare CompanyNDC labeler code 0338
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208083
Marketing start: Apr 20, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 0338-9545_b0a47c5e-911b-4b12-a0d1-a4425f173eecSPL ID b0a47c5e-911b-4b12-a0d1-a4425f173eecSPL set ID 44fa506b-90ac-42de-831b-5f3f1a500fc0RxCUI 309335, 309336, 309339UNII EH6D7113I8
Pharmacologic class: Lincosamide Antibacterial

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

N400338954524 followed by a unit qualifier and the quantity

Package 00338-9545-24. 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 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Clindamycin Phosphate in Sodium Chloride Injection contains clindamycin, a lincosamide antibacterial indicated for the treatment of the following in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • Serious infections caused by susceptible anaerobic bacteria ( 1.1 ) • Infections Due to Susceptible Isolates of Streptococci, Pneumococci and Staphylococci. ( 1.2 ) • Lower Respiratory Tract Infections. ( 1.3 ) • Skin and Skin Structure Infections. ( 1.4 ) • Gynecological Infections. ( 1.5 ) • Intra-abdominal Infections. ( 1.6 ) • Septicemia. ( 1.7 ) • Bone and Joint Infections. ( 1.8 ) Limitation of use Since clindamycin does not diffuse adequately…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-9545

What is NDC 0338-9545?: 0338-9545 is the product NDC for clindamycin phosphate, Clindamycin phosphate 300 mg/50mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: clindamycin phosphate.
What is the active ingredient?: Clindamycin phosphate.
Who is the labeler?: Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for clindamycin phosphate?: 70 other product NDCs are listed under this name. See all clindamycin phosphate 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 clindamycin phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	SolutionTopical	Rising Pharma Holdings, Inc.	16571-256	16571-0256-6016571-0256-69
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Aurobindo Pharma Limited	59651-806	59651-0806-3059651-0806-60
Clindamycin Phosphateclindamycin phosphate topical	Clindamycin phosphate 10 mg/mL	SolutionTopical	Carnegie Pharmaceuticals, LLC	80005-131	80005-0131-0980005-0131-38
Clindamycin phosphateclindamycin phosphate topical	Clindamycin phosphate 10 mg/mL	SolutionTopical	i3 Pharmaceuticals, LLC	72319-696	72319-0696-60
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Solaris Pharma Corporation	73473-300	73473-0300-3073473-0300-60
Clindamycin Phosphate	Clindamycin phosphate 1 g/10mL	GelTopical	Solaris Pharma Corporation	73473-302	73473-0302-75
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-623	46708-0623-3046708-0623-60
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-623	62332-0623-3062332-0623-60
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	Aerosol, FoamTopical	GLENMARK PHARMACEUTICALS INC., USA	68462-605	68462-0605-2768462-0605-94
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Viona Pharmaceuticals Inc	72578-118	72578-0118-0172578-0118-02

All 71 clindamycin phosphate NDCs

Other NDCs under NDA 208083

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

FDA NDC Directory listings under NDA 208083
Product	Strength	Form · route	Labeler	Product NDC
clindamycin phosphate	Clindamycin phosphate 600 mg/50mL	Injection, SolutionIntravenous	Baxter Healthcare Company	0338-9549
clindamycin phosphate	Clindamycin phosphate 900 mg/50mL	Injection, SolutionIntravenous	Baxter Healthcare Company	0338-9553