What is NDC 49999-347?

49999-347 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Quality Care Products LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Quality Care Products LLC, NDC labeler code 49999. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tizanidine Hydrochloride?

54 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tizanidine Hydrochloride NDC 49999-347

NDC codes

FDA NDC Directory

Product NDC (as listed)49999-347Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49999-0347Add 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 NDC	11-digit (billing)	Package
49999-347-01	4999903470149999034701	120 TABLET in 1 BOTTLE, PLASTIC (49999-347-01)Marketed from Nov 23, 2010
49999-347-30	4999903473049999034730	30 TABLET in 1 BOTTLE, PLASTIC (49999-347-30)Marketed from Nov 23, 2010
49999-347-60	4999903476049999034760	60 TABLET in 1 BOTTLE, PLASTIC (49999-347-60)Marketed from Nov 23, 2010
49999-347-90	4999903479049999034790	90 TABLET in 1 BOTTLE, PLASTIC (49999-347-90)Marketed from Nov 23, 2010

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): Tizanidine Hydrochloride
Generic name (nonproprietary): tizanidine hydrochloride
Active ingredients: Tizanidine hydrochloride — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Quality Care Products LLCNDC labeler code 49999
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076286
Marketing start: Nov 23, 2010
Marketing end: Apr 30, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 49999-347_adbf3ce7-64fd-4df3-aa6f-9f4b459b2976SPL ID adbf3ce7-64fd-4df3-aa6f-9f4b459b2976SPL set ID 87f8a776-e8ae-4aed-a221-98ca72a2bedfRxCUI 313413UNII B53E3NMY5C
Pharmacologic class: Central alpha-2 Adrenergic Agonist

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

N449999034701 followed by a unit qualifier and the quantity

Package 49999-0347-01. 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 Dec 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49999-347

What is NDC 49999-347?: 49999-347 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Quality Care Products LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tizanidine Hydrochloride.
What is the active ingredient?: Tizanidine hydrochloride.
Who is the labeler?: Quality Care Products LLC, NDC labeler code 49999. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tizanidine Hydrochloride?: 54 other product NDCs are listed under this name. See all Tizanidine 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 Tizanidine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tizanidine Hydrochloride	Tizanidine hydrochloride 8 mg/1	CapsuleOral	Trifluent Pharma, LLC	73352-089	73352-0089-60
tizanidine hydrochloride	Tizanidine hydrochloride 8 mg/1	CapsuleOral	Advagen Pharma Limited	72888-161	72888-0161-15
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0474	80425-0474-0180425-0474-0280425-0474-03+1 more
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8776	68788-8776-0168788-8776-0268788-8776-03+3 more
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0448	80425-0448-0180425-0448-0280425-0448-03
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8747	68788-8747-0168788-8747-0268788-8747-03+3 more
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8478	68788-8478-0168788-8478-0368788-8478-06+1 more
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2559	71335-2559-0171335-2559-0271335-2559-03+1 more
tizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2872	71335-2872-0171335-2872-0271335-2872-03+2 more
tizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-505	72789-0505-77

All 55 Tizanidine Hydrochloride NDCs

Other NDCs under ANDA 076286

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

FDA NDC Directory listings under ANDA 076286
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	NorthStar Rx LLC	16714-171
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	NorthStar Rx LLC	16714-172
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Quality Care Products, LLC	35356-662
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-455
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	A-S Medication Solutions	50090-0811
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-0840
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-6756
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-6757
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	AvPAK	50268-759
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	AvPAK	50268-760
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Northwind Health Company, LLC	51655-603
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-179
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-180
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-505
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-694
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Proficient Rx LP	63187-009
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Bryant Ranch Prepack	63629-1673
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-3209
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Redpharm Drug	67296-2263
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Redpharm Drug	67296-2316

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