NDC codes

FDA NDC Directory
Product NDC (as listed)65862-329Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0329Add 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
65862-329-0165862032901100 TABLET in 1 BOTTLE (65862-329-01)Marketed from Mar 6, 2024
65862-329-04658620329041 BLISTER PACK in 1 CARTON (65862-329-04) / 4 TABLET in 1 BLISTER PACKMarketed from Aug 4, 2008
65862-329-0565862032905500 TABLET in 1 BOTTLE (65862-329-05)Marketed from Mar 6, 2024
65862-329-08658620329083 BLISTER PACK in 1 CARTON (65862-329-08) / 4 TABLET in 1 BLISTER PACKMarketed from Aug 4, 2008
65862-329-106586203291010 BLISTER PACK in 1 CARTON (65862-329-10) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 4, 2008
65862-329-20658620329205 BLISTER PACK in 1 CARTON (65862-329-20) / 4 TABLET in 1 BLISTER PACKMarketed from Aug 4, 2008

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)
Alendronate Sodium
Generic name (nonproprietary)
alendronate sodium
Active ingredients
Alendronate sodium — 70 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090124
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 65862-329_c2dfac3c-41f9-42fa-bb6b-54b3fd9d1512SPL ID c2dfac3c-41f9-42fa-bb6b-54b3fd9d1512SPL set ID 815a87c4-e489-4eb9-9a2e-fb7a16642f01RxCUI 904396, 904419, 904431UNII 2UY4M2U3RAUPC 0365862329011
Pharmacologic class
Bisphosphonate

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

N465862032901 followed by a unit qualifier and the quantity

Package 65862-0329-01. 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 .

Indications (excerpt from the label)

Alendronate sodium is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.6 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increases bone mass a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-329

What is NDC 65862-329?
65862-329 is the product NDC for Alendronate Sodium, Alendronate sodium 70 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Alendronate Sodium.
What is the active ingredient?
Alendronate sodium.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alendronate Sodium?
27 other product NDCs are listed under this name. See all Alendronate Sodium 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 Alendronate Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alendronate SodiumAlendronate sodium 70 mg/75mLSolutionOralANI Pharmaceuticals, Inc.70954-26470954-0264-10
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralEXELAN PHARMACEUTICALS INC.76282-68176282-0681-46
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralEXELAN PHARMACEUTICALS INC.76282-68276282-0682-46
Alendronate SodiumAlendronate sodium 70 mg/75mLSolutionOralHikma Pharmaceuticals USA Inc.0054-028200054-0282-59
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralREMEDYREPACK INC.70518-119270518-1192-01
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-713068788-7130-04
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralREMEDYREPACK INC.70518-003370518-0033-00
Alendronate SodiumAlendronate sodium 10 mg/1TabletOralNorthStar Rx LLC16714-63116714-0631-0116714-0631-0216714-0631-11
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralNorthStar Rx LLC16714-63216714-0632-0116714-0632-0216714-0632-11
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralNorthStar Rx LLC16714-63316714-0633-0116714-0633-0216714-0633-11

All 28 Alendronate Sodium NDCs

Other NDCs under ANDA 090124

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

FDA NDC Directory listings under ANDA 090124
ProductStrengthForm · routeLabelerProduct NDC
Alendronate SodiumAlendronate sodium 10 mg/1TabletOralNorthStar Rx LLC16714-631
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralNorthStar Rx LLC16714-632
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralNorthStar Rx LLC16714-633
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralA-S Medication Solutions50090-3126
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralA-S Medication Solutions50090-5474
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralA-S Medication Solutions50090-5677
Alendronate SodiumAlendronate sodium 10 mg/1TabletOralRising Pharma Holdings, Inc.64980-340
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralRising Pharma Holdings, Inc.64980-341
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralRising Pharma Holdings, Inc.64980-342
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralProficient Rx LP71205-048

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