NDC codes

FDA NDC Directory
Product NDC (as listed)0338-4114Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-4114Add 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
0338-4114-24003384114240033841142424 BAG in 1 CASE (0338-4114-24) / 50 mL in 1 BAG (0338-4114-50)Marketed from Aug 9, 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)
Clindamycin phosphate
Generic name (nonproprietary)
clindamycin phosphate
Active ingredients
Clindamycin phosphate — 900 mg/50mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Baxter Healthcare CompanyNDC labeler code 0338
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208084
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 0338-4114_f578b16a-78b1-443f-b96a-e595ad9e145aSPL ID f578b16a-78b1-443f-b96a-e595ad9e145aSPL set ID 406534a6-2234-4735-ba8f-7de4c87592e6RxCUI 309335, 309336UNII 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

N400338411424 followed by a unit qualifier and the quantity

Package 00338-4114-24. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin Injection USP in 5% Dextrose products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection USP in 5% Dextrose products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-4114

What is NDC 0338-4114?
0338-4114 is the product NDC for Clindamycin phosphate, Clindamycin phosphate 900 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalRising Pharma Holdings, Inc.16571-25616571-0256-6016571-0256-69
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalAurobindo Pharma Limited59651-80659651-0806-3059651-0806-60
Clindamycin Phosphateclindamycin phosphate topicalClindamycin phosphate 10 mg/mLSolutionTopicalCarnegie Pharmaceuticals, LLC80005-13180005-0131-0980005-0131-38
Clindamycin phosphateclindamycin phosphate topicalClindamycin phosphate 10 mg/mLSolutionTopicali3 Pharmaceuticals, LLC72319-69672319-0696-60
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalSolaris Pharma Corporation73473-30073473-0300-3073473-0300-60
Clindamycin PhosphateClindamycin phosphate 1 g/10mLGelTopicalSolaris Pharma Corporation73473-30273473-0302-75
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalAlembic Pharmaceuticals Limited46708-62346708-0623-3046708-0623-60
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalAlembic Pharmaceuticals Inc.62332-62362332-0623-3062332-0623-60
Clindamycin PhosphateClindamycin phosphate 10 mg/gAerosol, FoamTopicalGLENMARK PHARMACEUTICALS INC., USA68462-60568462-0605-2768462-0605-94
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalViona Pharmaceuticals Inc72578-11872578-0118-0172578-0118-02

All 71 Clindamycin phosphate NDCs

Other NDCs under ANDA 208084

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

FDA NDC Directory listings under ANDA 208084
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin phosphateClindamycin phosphate 300 mg/50mLInjection, SolutionIntravenousBaxter Healthcare Company0338-3410
Clindamycin phosphateClindamycin phosphate 600 mg/50mLInjection, SolutionIntravenousBaxter Healthcare Company0338-3612
Clindamycin phosphateClindamycin phosphate 600 mg/50mLInjection, SolutionIntravenousBaxter Healthcare Company0338-3616
Clindamycin phosphateClindamycin phosphate 900 mg/50mLInjection, SolutionIntravenousBaxter Healthcare Company0338-3814
Clindamycin phosphateClindamycin phosphate 600 mg/50mLInjection, SolutionIntravenousBaxter Healthcare Corporation43066-993
Clindamycin phosphateClindamycin phosphate 900 mg/50mLInjection, SolutionIntravenousBaxter Healthcare Corporation43066-995

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