NDC codes

FDA NDC Directory
Product NDC (as listed)65862-884Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0884Add 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
65862-884-0165862088401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-01)Marketed from Jun 13, 2016
65862-884-0565862088405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-05)Marketed from Jun 13, 2016
65862-884-306586208843030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-30)Marketed from Jun 13, 2016
65862-884-99658620884991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-884-99)Marketed from Jun 13, 2016

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)
Minocycline Hydrochloride
Generic name (nonproprietary)
minocycline hydrochloride
Active ingredients
Minocycline hydrochloride — 80 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202261
Marketing start
Listing expires
Other FDA classes
Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
Identifiers
Product ID 65862-884_5569f0f6-b36f-4149-aee7-2699fa5ebe53SPL ID 5569f0f6-b36f-4149-aee7-2699fa5ebe53SPL set ID e7b88a48-12b3-461d-b356-0d7ae4e8fd44RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665UNII 0020414E5UUPC 0365862555304
Pharmacologic class
Tetracycline-class Drug

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

N465862088401 followed by a unit qualifier and the quantity

Package 65862-0884-01. 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 .

Indications (excerpt from the label)

Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14) ]. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12) ] . Minocycline hydrochloride is …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-884

What is NDC 65862-884?
65862-884 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 80 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Minocycline Hydrochloride.
What is the active ingredient?
Minocycline hydrochloride.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Minocycline Hydrochloride?
124 other product NDCs are listed under this name. See all Minocycline 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 Minocycline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Minocycline HydrochlorideMinocycline hydrochloride 100 mg/1CapsuleOralREMEDYREPACK INC.70518-456570518-4565-00
minocycline hydrochlorideMinocycline hydrochloride 65 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-53268382-0532-0168382-0532-0568382-0532-06+3 more
minocycline hydrochlorideMinocycline hydrochloride 115 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-53468382-0534-0168382-0534-0568382-0534-06+3 more
minocycline hydrochlorideMinocycline hydrochloride 55 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-55068382-0550-0168382-0550-0568382-0550-06+3 more
minocycline hydrochlorideMinocycline hydrochloride 55 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-115370771-1153-0070771-1153-0170771-1153-03+3 more
minocycline hydrochlorideMinocycline hydrochloride 65 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-115470771-1154-0070771-1154-0170771-1154-03+3 more
minocycline hydrochlorideMinocycline hydrochloride 115 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-115870771-1158-0070771-1158-0170771-1158-03+3 more
Minocycline HydrochlorideMinocycline hydrochloride 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-039080425-0390-0180425-0390-0280425-0390-03
Minocycline hydrochlorideMinocycline hydrochloride 100 mg/1CapsuleOralNorthwind Health Company, LLC82868-01782868-0017-60
Minocycline hydrochlorideMinocycline hydrochloride 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-031480425-0314-0180425-0314-0280425-0314-03

All 125 Minocycline Hydrochloride NDCs

Other NDCs under ANDA 202261

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

FDA NDC Directory listings under ANDA 202261
ProductStrengthForm · routeLabelerProduct NDC
Minocycline HydrochlorideMinocycline hydrochloride 105 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-885
Minocycline HydrochlorideMinocycline hydrochloride 55 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-883
Minocycline HydrochlorideMinocycline hydrochloride 45 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-554
Minocycline HydrochlorideMinocycline hydrochloride 135 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-558
Minocycline HydrochlorideMinocycline hydrochloride 65 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-555
Minocycline HydrochlorideMinocycline hydrochloride 90 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-556
Minocycline HydrochlorideMinocycline hydrochloride 115 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-557

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in