Home NDC 0781-1078 Atenolol
Product NDC 0781-1078
11-digit product format 007811078
Labeler code 0781
Product ID 0781-1078_1e5460cc-8e8d-44cf-b14b-7129a0e95122
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA074052
Marketing category ANDA
Marketing start 1992-05-01
Marketing end 2021-12-31
Substance ATENOLOL
Active strength 25 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog .
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 ea99ee380514…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL TABLET [SANDOZ INC] 15 ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL TABLET [READYMEDS] 15 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL TABLET [SANDOZ INC] 15 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL TABLET [READYMEDS] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL TABLET [SANDOZ INC] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL TABLET [READYMEDS] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL TABLET [READYMEDS] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL TABLET [SANDOZ INC] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATENOLOL TABLET [SANDOZ INC] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATENOLOL TABLET [READYMEDS] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL TABLET [READYMEDS] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL TABLET [SANDOZ INC] 15 ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATENOLOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL TABLET [REDPHARM DRUG INC.] 2 ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL TABLET [REDPHARM DRUG INC.] 2 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL TABLET [REDPHARM DRUG INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATENOLOL TABLET [REDPHARM DRUG INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL TABLET [REDPHARM DRUG INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL TABLET [REDPHARM DRUG INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-1078-01 00781107801 100 TABLET in 1 BOTTLE (0781-1078-01) 100 tablet 1992-05-01 2021-11-30 No No Current 0781-1078-10 00781107810 1000 TABLET in 1 BOTTLE (0781-1078-10) 1000 tablet 1992-05-01 2021-11-30 No No Current