What is NDC 80425-0103?

80425-0103 is the product NDC for Clindamycin HCL, Clindamycin hydrochloride 300 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 HCL?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clindamycin HCL NDC 80425-0103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0103Add 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
80425-0103-1	8042501030180425010301	30 CAPSULE in 1 BOTTLE (80425-0103-1)Marketed from Mar 23, 2001

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCL
Generic name (nonproprietary): clindamycin hcl
Active ingredients: Clindamycin hydrochloride — 300 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065061
Marketing start: Mar 23, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 80425-0103_2a99aae5-c901-7940-e063-6294a90a4146SPL ID 2a99aae5-c901-7940-e063-6294a90a4146SPL set ID b43dc396-17ef-a523-e053-2a95a90ac872RxCUI 284215UNII T20OQ1YN1W
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425010301 followed by a unit qualifier and the quantity

Package 80425-0103-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Indications and Usage Section INDICATIONS AND USAGE Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP 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 colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less tox…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0103

What is NDC 80425-0103?: 80425-0103 is the product NDC for Clindamycin HCL, Clindamycin hydrochloride 300 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clindamycin HCL.
What is the active ingredient?: Clindamycin hydrochloride.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 HCL?: 1 other product NDC are listed under this name. See all Clindamycin HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clindamycin HCL	Clindamycin hydrochloride 300 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0145	80425-0145-0180425-0145-0280425-0145-03

Other NDCs under ANDA 065061

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

FDA NDC Directory listings under ANDA 065061
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Major Pharmaceuticals	0904-5959
Clindamycin hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	A-S Medication Solutions	50090-0967
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	A-S Medication Solutions	50090-1985
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	A-S Medication Solutions	50090-7007
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-373
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Northwind Health Company, LLC	51655-964
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-7276
Clindamycin hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	Proficient Rx LP	63187-141
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Proficient Rx LP	63187-247
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-692
Clindamycin hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	63304-693
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	NuCare Pharmaceuticals, Inc.	68071-3939
Clindamycin hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4257
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4335
Clindamycin Hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	American Health Packaging	68084-243
Clindamycin Hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	American Health Packaging	68084-244
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4583
Clindamycin hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0200
Clindamycin hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0320
Clindamycin hydrochloride	Clindamycin hydrochloride 300 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-207

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