Prescription drug · ANDA

Alendronate Sodium NDC 71205-048

Alendronate sodium 70 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-048Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0048Add 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
71205-048-0471205004804712050048041 BLISTER PACK in 1 CARTON (71205-048-04) / 4 TABLET in 1 BLISTER PACKMarketed from Jun 1, 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)
Alendronate Sodium
Generic name (nonproprietary)
alendronate sodium
Active ingredients
Alendronate sodium — 70 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
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 71205-048_6db7f218-1343-4b68-b72d-6605f1838e97SPL ID 6db7f218-1343-4b68-b72d-6605f1838e97SPL set ID 6c4d13fb-490c-4ea9-9b04-003c8d8e9f0cRxCUI 904431UNII 2UY4M2U3RAUPC 0371205048044
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

N471205004804 followed by a unit qualifier and the quantity

Package 71205-0048-04. 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)

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 increase …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-048

What is NDC 71205-048?
71205-048 is the product NDC for Alendronate Sodium, Alendronate sodium 70 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, 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?
Proficient Rx LP, NDC labeler code 71205. 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 35 mg/1TabletOralA-S Medication Solutions50090-5474
Alendronate SodiumAlendronate sodium 10 mg/1TabletOralAurobindo Pharma Limited65862-327
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralAurobindo Pharma Limited65862-328
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralAurobindo Pharma Limited65862-329
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralA-S Medication Solutions50090-5677
Alendronate SodiumAlendronate sodium 35 mg/1TabletOralNorthStar Rx LLC16714-632
Alendronate SodiumAlendronate sodium 10 mg/1TabletOralNorthStar Rx LLC16714-631
Alendronate SodiumAlendronate sodium 70 mg/1TabletOralNorthStar Rx LLC16714-633
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/1TabletOralA-S Medication Solutions50090-3126

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in