NDC codes

FDA NDC Directory
Product NDC (as listed)67877-643Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0643Add 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
67877-643-0167877064301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-643-01)Marketed from Sep 30, 2016
67877-643-0567877064305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-643-05)Marketed from Sep 30, 2016
67877-643-146787706431410 BLISTER PACK in 1 CARTON (67877-643-14) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 30, 2016
67877-643-306787706433030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-643-30)Marketed from Sep 30, 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 — 65 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204453
Marketing start
Listing expires
Other FDA classes
Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
Identifiers
Product ID 67877-643_51213aa1-873c-4b55-a36d-3ebbb73fa220SPL ID 51213aa1-873c-4b55-a36d-3ebbb73fa220SPL set ID a8f95207-b259-4f50-87f2-3652d9268890RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665UNII 0020414E5U
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

N467877064301 followed by a unit qualifier and the quantity

Package 67877-0643-01. 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 is 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 ext…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-643

What is NDC 67877-643?
67877-643 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 65 mg/1 tablet, film coated, extended release, listed with the FDA by Ascend Laboratories, LLC. 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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?
116 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 117 Minocycline Hydrochloride NDCs

Other NDCs under ANDA 204453

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

FDA NDC Directory listings under ANDA 204453
ProductStrengthForm · routeLabelerProduct NDC
Minocycline HydrochlorideMinocycline hydrochloride 135 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1853
Minocycline HydrochlorideMinocycline hydrochloride 45 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1854
Minocycline HydrochlorideMinocycline hydrochloride 65 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1867
Minocycline HydrochlorideMinocycline hydrochloride 115 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1868
Minocycline HydrochlorideMinocycline hydrochloride 90 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2710
Minocycline HydrochlorideMinocycline hydrochloride 45 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2711
Minocycline HydrochlorideMinocycline hydrochloride 90 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2201
Minocycline HydrochlorideMinocycline hydrochloride 90 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-576
Minocycline HydrochlorideMinocycline hydrochloride 135 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-577
Minocycline HydrochlorideMinocycline hydrochloride 45 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-578
Minocycline HydrochlorideMinocycline hydrochloride 45 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9211
Minocycline HydrochlorideMinocycline hydrochloride 105 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9208
Minocycline HydrochlorideMinocycline hydrochloride 115 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9209
Minocycline HydrochlorideMinocycline hydrochloride 135 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9210
Minocycline HydrochlorideMinocycline hydrochloride 65 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9213
Minocycline HydrochlorideMinocycline hydrochloride 55 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9212
Minocycline HydrochlorideMinocycline hydrochloride 80 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9214
Minocycline HydrochlorideMinocycline hydrochloride 90 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-9215
Minocycline HydrochlorideMinocycline hydrochloride 115 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-644
Minocycline HydrochlorideMinocycline hydrochloride 45 mg/1Tablet, Film coated, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-523

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