NDC codes

FDA NDC Directory
Product NDC (as listed)43817-135Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43817-0135Add 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
43817-135-0443817013504438170135046 BLISTER PACK in 1 CARTON (43817-135-04) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (43817-135-03)Marketed from Jan 17, 2017

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)
Rizatriptan Benzoate
Generic name (nonproprietary)
rizatriptan benzoate
Active ingredients
Rizatriptan benzoate — 10 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Panacea Biotec LimitedNDC labeler code 43817
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204722
Marketing start
Listing expires
Other FDA classes
Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers
Product ID 43817-135_28d0cbcc-59cc-7cf4-e063-6294a90a9b53SPL ID 28d0cbcc-59cc-7cf4-e063-6294a90a9b53SPL set ID 9c70370d-72ac-e062-e25c-97d57e6397abRxCUI 312837, 312839UNII WR978S7QHHUPC 0343817135047, 0343817135030, 0343817133036
Pharmacologic class
Serotonin-1b and Serotonin-1d Receptor 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

N443817013504 followed by a unit qualifier and the quantity

Package 43817-0135-04. 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)

Rizatriptan Benzoate Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43817-135

What is NDC 43817-135?
43817-135 is the product NDC for Rizatriptan Benzoate, Rizatriptan benzoate 10 mg/1 tablet, orally disintegrating, listed with the FDA by Panacea Biotec Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rizatriptan Benzoate.
What is the active ingredient?
Rizatriptan benzoate.
Who is the labeler?
Panacea Biotec Limited, NDC labeler code 43817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rizatriptan Benzoate?
56 other product NDCs are listed under this name. See all Rizatriptan Benzoate 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 Rizatriptan Benzoate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-053580425-0535-01
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-436270518-4362-00
Rizatriptan BenzoateRizatriptan benzoate 5 mg/1TabletOralDirect_Rx72189-51272189-0512-18
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1Tablet, Film coatedOralDirect_Rx72189-44772189-0447-18
Rizatriptan BenzoateRizatriptan benzoate 5 mg/1TabletOralDirect Rx72189-31672189-0316-18
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1TabletOraldirect rx72189-25872189-0258-1272189-0258-18
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1TabletOralDIRECT RX61919-65661919-0656-12
Rizatriptan BenzoateRizatriptan benzoate 5 mg/1TabletOralDIRECT RX61919-39461919-0394-18
Rizatriptan BenzoateRizatriptan benzoate 5 mg/1Tablet, Orally disintegratingOralUnichem Pharmaceuticals (USA), Inc.29300-26829300-0268-2129300-0268-8129300-0268-91
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1Tablet, Orally disintegratingOralUnichem Pharmaceuticals (USA), Inc.29300-26929300-0269-2129300-0269-8129300-0269-91

All 57 Rizatriptan Benzoate NDCs

Other NDCs under ANDA 204722

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

FDA NDC Directory listings under ANDA 204722
ProductStrengthForm · routeLabelerProduct NDC
Rizatriptan BenzoateRizatriptan benzoate 5 mg/1Tablet, Orally disintegratingOralPanacea Biotec Limited43817-133
Rizatriptan BenzoateRizatriptan benzoate 5 mg/1Tablet, Orally disintegratingOralBionpharma Inc.,69452-156
Rizatriptan BenzoateRizatriptan benzoate 10 mg/1Tablet, Orally disintegratingOralBionpharma Inc.,69452-157

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