Prescription drug · ANDA

Clindamycin hydrochloride NDC 63187-141

Clindamycin hydrochloride 300 mg/1 · Capsule · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-141Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0141Add 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
63187-141-206318701412020 CAPSULE in 1 BOTTLE (63187-141-20)Marketed from Aug 1, 2016
63187-141-216318701412121 CAPSULE in 1 BOTTLE (63187-141-21)Marketed from Aug 3, 2015
63187-141-286318701412828 CAPSULE in 1 BOTTLE (63187-141-28)Marketed from Aug 3, 2015
63187-141-306318701413030 CAPSULE in 1 BOTTLE (63187-141-30)Marketed from Aug 3, 2015
63187-141-406318701414040 CAPSULE in 1 BOTTLE (63187-141-40)Marketed from Aug 3, 2015
63187-141-446318701414444 CAPSULE in 1 BOTTLE (63187-141-44)Marketed from Jun 7, 2022
63187-141-606318701416060 CAPSULE in 1 BOTTLE (63187-141-60)Marketed from Jun 7, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 hydrochloride
Generic name (nonproprietary)
clindamycin hydrochloride
Active ingredients
Clindamycin hydrochloride — 300 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065061
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8SPL ID 2dfd4382-3405-48c3-b7e1-7c19d82901d8SPL set ID 158e6c0c-1ca3-49a6-84fd-54d8fde7c2a7RxCUI 197518, 284215UNII T20OQ1YN1WUPC 0363187141288, 0363187247287
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

N463187014120 followed by a unit qualifier and the quantity

Package 63187-0141-20. 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 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 WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralHAWAII REPACK, INC.85534-0087
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralBryant Ranch Prepack71335-0320
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralHAWAII REPACK, INC.85534-0088
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-005
Clindamycin HydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralAmerican Health Packaging68084-243
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralAmerican Health Packaging68084-244
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralProficient Rx LP63187-247
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralA-S Medication Solutions50090-1985
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralMajor Pharmaceuticals0904-5959
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralA-S Medication Solutions50090-0967
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralNuCare Pharmaceuticals, Inc.68071-3939
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.63304-692
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.63304-693
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-373
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralREMEDYREPACK INC.70518-4583
Clindamycin HCLClindamycin hydrochloride 300 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0103
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-207
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralBryant Ranch Prepack71335-0200
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4257
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralCardinal Health 107, LLC55154-7276

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Clindamycin hydrochloride NDC 63187-141 | Med-Code