NDC codes

FDA NDC Directory
Product NDC (as listed)63304-693Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0693Add 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
63304-693-016330406930163304069301100 CAPSULE in 1 BOTTLE (63304-693-01)Marketed from Mar 23, 2001
63304-693-03633040693036330406930310 CAPSULE in 1 BOTTLE (63304-693-03)Marketed from Mar 23, 2001
63304-693-056330406930563304069305500 CAPSULE in 1 BOTTLE (63304-693-05)Marketed from Mar 23, 2001
63304-693-16633040693166330406931616 CAPSULE in 1 BOTTLE (63304-693-16)Marketed from Mar 23, 2001
63304-693-776330406937763304069377100 CAPSULE in 1 CARTON (63304-693-77)Marketed from Mar 23, 2001

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
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
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 63304-693_5497511e-22f2-c613-e063-6394a90ac56cSPL ID 5497511e-22f2-c613-e063-6394a90ac56cSPL set ID 1dbd8448-c1e5-46df-8060-50ef82380445RxCUI 197518, 284215UNII T20OQ1YN1WUPC 0363304693010
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

N463304069301 followed by a unit qualifier and the quantity

Package 63304-0693-01. 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 . 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 BOXED WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-693

What is NDC 63304-693?
63304-693 is the product NDC for Clindamycin hydrochloride, Clindamycin hydrochloride 300 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clindamycin hydrochloride.
What is the active ingredient?
Clindamycin hydrochloride.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 hydrochloride?
88 other product NDCs are listed under this name. See all Clindamycin hydrochloride 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 hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-00587441-0005-01
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralCoupler LLC67046-207367046-2073-03
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralREMEDYREPACK INC.70518-458370518-4583-0070518-4583-01
Clindamycin HydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralREMEDYREPACK INC.70518-435370518-4353-00
Clindamycin HydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralST. MARY'S MEDICAL PARK PHARMACY60760-82860760-0828-2860760-0828-60
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-041680425-0416-0180425-0416-0280425-0416-03
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-82760760-0827-1060760-0827-30
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-868568788-8685-0168788-8685-0268788-8685-03+4 more
Clindamycin HydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-855868788-8558-0068788-8558-0168788-8558-02+5 more
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralREMEDYREPACK INC.70518-377270518-3772-0070518-3772-0170518-3772-02+3 more

All 89 Clindamycin hydrochloride NDCs

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 HCLClindamycin hydrochloride 300 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0103
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralMajor Pharmaceuticals0904-5959
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralA-S Medication Solutions50090-0967
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralA-S Medication Solutions50090-1985
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralA-S Medication Solutions50090-7007
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-373
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralNorthwind Health Company, LLC51655-964
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralCardinal Health 107, LLC55154-7276
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralProficient Rx LP63187-141
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralProficient Rx LP63187-247
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.63304-692
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralNuCare Pharmaceuticals, Inc.68071-3939
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4257
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4335
Clindamycin HydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralAmerican Health Packaging68084-243
Clindamycin HydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralAmerican Health Packaging68084-244
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralREMEDYREPACK INC.70518-4583
Clindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralBryant Ranch Prepack71335-0200
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralBryant Ranch Prepack71335-0320
Clindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-207

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