NDC codes

FDA NDC Directory
Product NDC (as listed)64380-795Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0795Add 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
64380-795-066438007950664380079506100 TABLET in 1 BOTTLE (64380-795-06)Marketed from Apr 11, 2018
64380-795-0864380079508643800795081000 TABLET in 1 BOTTLE (64380-795-08)Marketed from Apr 11, 2018

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)
Cyproheptadine Hydrochloride
Generic name (nonproprietary)
cyproheptadine hydrochloride
Active ingredients
Cyproheptadine hydrochloride — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Strides Pharma Science LimitedNDC labeler code 64380
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209172
Marketing start
Listing expires
Identifiers
Product ID 64380-795_a8e64191-720a-458a-acb7-52b0353dc67cSPL ID a8e64191-720a-458a-acb7-52b0353dc67cSPL set ID b28c2ca0-140d-44d8-a59e-75fbfe8eabddRxCUI 866144UNII NJ82J0F8QCUPC 0364380795063

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

N464380079506 followed by a unit qualifier and the quantity

Package 64380-0795-06. 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)

INDICATIONS AND USAGE Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-795

What is NDC 64380-795?
64380-795 is the product NDC for Cyproheptadine Hydrochloride, Cyproheptadine hydrochloride 4 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cyproheptadine Hydrochloride.
What is the active ingredient?
Cyproheptadine hydrochloride.
Who is the labeler?
Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cyproheptadine Hydrochloride?
34 other product NDCs are listed under this name. See all Cyproheptadine 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 Cyproheptadine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 2 mg/1TabletOralPANGEA PHARMACEUTICALS, LLC81279-12981279-0129-3081279-0129-60
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 4 mg/1TabletOralTRUPHARMA, LLC52817-41552817-0415-1052817-0415-50
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-466770518-4667-00
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 4 mg/1TabletOralAvPAK50268-20150268-0201-15
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 2 mg/5mLSolutionOralAtlantic Biologicals Corp.17856-118517856-1185-0117856-1185-02
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 2 mg/5mLSolutionOralQUAGEN PHARMACEUTICALS LLC70752-18570752-0185-12
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-351770518-3517-00
Cyproheptadine HydrochlorideCyproheptadine 2 mg/5mLSolutionOralPatrin Pharma, Inc.39328-54439328-0544-16
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 4 mg/1TabletOralRising Pharma Holdings, Inc.16571-80516571-0805-0116571-0805-10
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 2 mg/5mLSyrupOralTris Pharma Inc27808-09927808-0099-01

All 35 Cyproheptadine Hydrochloride NDCs

Other NDCs under ANDA 209172

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

FDA NDC Directory listings under ANDA 209172
ProductStrengthForm · routeLabelerProduct NDC
Cyproheptadine HydrochlorideCyproheptadine hydrochloride 4 mg/1TabletOralBryant Ranch Prepack71335-1107

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