What is NDC 68180-460?

68180-460 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 55 mg/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals, Inc..

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Minocycline Hydrochloride NDC 68180-460

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-460Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0460Add the package segment from the table below.

Product information

Brand name (proprietary): Minocycline Hydrochloride
Generic name (nonproprietary): minocycline hydrochloride
Active ingredients: Minocycline hydrochloride — 55 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091424
Marketing start: Feb 22, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
Identifiers: Product ID 68180-460_ad320f99-9382-4ef0-b6b6-86542020555aSPL ID ad320f99-9382-4ef0-b6b6-86542020555aSPL set ID 3b1e1cf1-ebd2-4aba-a219-9f9939fdb03bRxCUI 629695, 629697, 629699, 1013662UNII 0020414E5UUPC 0368180460060
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.

Product label

Current FDA label (SPL), effective Oct 30, 2023.

Indications (excerpt from the label)

Minocycline hydrochloride extended-release tablets USP are 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 ) 1.1 Indication Minocycline hydrochloride extended-release tablets USP are 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 USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have not been established beyond 12 weeks of use. This formulatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-460

What is NDC 68180-460?: 68180-460 is the product NDC for Minocycline Hydrochloride, Minocycline hydrochloride 55 mg/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?: Minocycline Hydrochloride.
What is the active ingredient?: Minocycline hydrochloride.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Minocycline Hydrochloride	Minocycline hydrochloride 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4565	70518-4565-00
minocycline hydrochloride	Minocycline hydrochloride 65 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-532	68382-0532-0168382-0532-0568382-0532-06+3 more
minocycline hydrochloride	Minocycline hydrochloride 115 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-534	68382-0534-0168382-0534-0568382-0534-06+3 more
minocycline hydrochloride	Minocycline hydrochloride 55 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-550	68382-0550-0168382-0550-0568382-0550-06+3 more
minocycline hydrochloride	Minocycline hydrochloride 55 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1153	70771-1153-0070771-1153-0170771-1153-03+3 more
minocycline hydrochloride	Minocycline hydrochloride 65 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1154	70771-1154-0070771-1154-0170771-1154-03+3 more
minocycline hydrochloride	Minocycline hydrochloride 115 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1158	70771-1158-0070771-1158-0170771-1158-03+3 more
Minocycline Hydrochloride	Minocycline hydrochloride 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0390	80425-0390-0180425-0390-0280425-0390-03
Minocycline hydrochloride	Minocycline hydrochloride 100 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-017	82868-0017-60
Minocycline hydrochloride	Minocycline hydrochloride 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0314	80425-0314-0180425-0314-0280425-0314-03

All 117 Minocycline Hydrochloride NDCs

Other NDCs under ANDA 091424

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

FDA NDC Directory listings under ANDA 091424
Product	Strength	Form · route	Labeler	Product NDC
Minocycline Hydrochloride	Minocycline hydrochloride 90 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-380
Minocycline Hydrochloride	Minocycline hydrochloride 45 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-379
Minocycline Hydrochloride	Minocycline hydrochloride 135 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-381