NDC codes

FDA NDC Directory
Product NDC (as listed)68382-923Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0923Add 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
68382-923-0568382092305500 TABLET, FILM COATED in 1 BOTTLE (68382-923-05)Marketed from Jul 12, 2017
68382-923-066838209230630 TABLET, FILM COATED in 1 BOTTLE (68382-923-06)Marketed from Jul 12, 2017
68382-923-776838209237710 BLISTER PACK in 1 CARTON (68382-923-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-923-30)Marketed from Jul 12, 2017
68382-923-86683820923861 BLISTER PACK in 1 CARTON (68382-923-86) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 12, 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)
Eletriptan hydrobromide
Generic name (nonproprietary)
eletriptan hydrobromide
Active ingredients
Eletriptan hydrobromide — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206409
Marketing start
Listing expires
Other FDA classes
Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers
Product ID 68382-923_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3SPL ID 669aad4d-c160-4be8-bca9-bdbaf0f3c8a3SPL set ID e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10RxCUI 359493, 359494UNII M41W832TA3
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

N468382092305 followed by a unit qualifier and the quantity

Package 68382-0923-05. 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)

Eletriptan hydrobromide tablets are a serotonin (5-HT 1B/ 1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use: Use only after a clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 ). Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide, reconsider the diagno…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-923

What is NDC 68382-923?
68382-923 is the product NDC for Eletriptan hydrobromide, Eletriptan hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eletriptan hydrobromide.
What is the active ingredient?
Eletriptan hydrobromide.
Who is the labeler?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eletriptan hydrobromide?
16 other product NDCs are listed under this name. See all Eletriptan hydrobromide 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 Eletriptan hydrobromide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Eletriptan HydrobromideEletriptan hydrobromide 20 mg/1Tablet, Film coatedOralApnar Pharma LP24689-16724689-0167-01
Eletriptan HydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralApnar Pharma LP24689-16824689-0168-01
Eletriptan hydrobromideEletriptan hydrobromide 20 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-44331722-0443-31
Eletriptan hydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-44431722-0444-3131722-0444-33
Eletriptan HydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-040880425-0408-01
Eletriptan HydrobromideEletriptan hydrobromide 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-10459651-0104-69
Eletriptan HydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-10559651-0105-6959651-0105-93
Eletriptan HydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-832063629-8320-0163629-8320-02
Eletriptan HydrobromideEletriptan hydrobromide 20 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-428700378-4287-85
Eletriptan HydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-428800378-4288-0800378-4288-85

All 17 Eletriptan hydrobromide NDCs

Other NDCs under ANDA 206409

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

FDA NDC Directory listings under ANDA 206409
ProductStrengthForm · routeLabelerProduct NDC
Eletriptan hydrobromideEletriptan hydrobromide 20 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-922
Eletriptan hydrobromideEletriptan hydrobromide 20 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1107
Eletriptan hydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1108
Eletriptan hydrobromideEletriptan hydrobromide 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2983

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