ALENDRONATE SODIUM

Product NDC: 70518-0033
11-digit product format: 705180033
Labeler code: 70518
Product ID: 70518-0033_4cd5394f-5f36-4207-e063-6394a90a76f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate sodium
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076768
Marketing category: ANDA
Marketing start: 2016-12-01
Substance: ALENDRONATE SODIUM
Active strength: 70 mg/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: ALENDRONATE SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALENDRONATE SODIUM	70 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	2UY4M2U3RA
Rxcui	904431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b55122e7-1795-3be6-8216-d42256d80e7d	Product name	2	20250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0a	Product name	1	20240513
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-0033-0	ALENDRONATE SODIUM	12 in 1 BLISTER PACK	TABLET	12		22
70518-0033-1	ALENDRONATE SODIUM	12 in 1 BOTTLE, PLASTIC	TABLET	12		22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0033	ALENDRONATE SODIUM TABLET [REMEDYREPACK INC.]	18	Current NDC, Legacy NDC, 2 package rows	20250524_c4358ba7-1bf8-4b0a-9407-5ac279d04555.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904431	alendronate sodium 70 MG Oral Tablet	PSN	c4358ba7-1bf8-4b0a-9407-5ac279d04555	22
904431	alendronic acid 70 MG Oral Tablet	SCD	c4358ba7-1bf8-4b0a-9407-5ac279d04555	22
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	c4358ba7-1bf8-4b0a-9407-5ac279d04555	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0033-0	70518003300	12 TABLET in 1 BLISTER PACK (70518-0033-0)	12 tablet	2016-12-01	0000-00-00	No	No	Current
70518-0033-1	70518003301	12 TABLET in 1 BOTTLE, PLASTIC (70518-0033-1)	12 tablet	2018-04-12	0000-00-00	No	No	Current