Prescription drug · ANDA

Minocycline Hydrochloride NDC 63629-9213

Minocycline hydrochloride 65 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-9213Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-9213Add 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
63629-9213-16362992130130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9213-1)Marketed from Mar 2, 2022

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)
Minocycline Hydrochloride
Generic name (nonproprietary)
minocycline hydrochloride
Active ingredients
Minocycline hydrochloride — 65 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
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 63629-9213_931b98ea-4357-4202-90a6-20521845b250SPL ID 931b98ea-4357-4202-90a6-20521845b250SPL set ID dddad9bc-a0a3-41bf-81e5-65d9903b14c6RxCUI 858372UNII 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

N463629921301 followed by a unit qualifier and the quantity

Package 63629-9213-01. 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 a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.1 Indication Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.2 Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has no…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-9213

What is NDC 63629-9213?
63629-9213 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 65 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 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 65 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-643
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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