Home NDC 0781-1182 Nadolol
Product NDC 0781-1182
11-digit product format 007811182
Labeler code 0781
Product ID 0781-1182_3374b237-5717-415f-a482-88f834d9b3a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nadolol
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA074501
Marketing category ANDA
Marketing start 2008-10-01
Marketing end 2019-11-30
Substance NADOLOL
Active strength 40 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 · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074501-001 NADOLOL NADOLOL 20MG TABLET / ORAL AB 1995-11-09 A074501-002 NADOLOL NADOLOL 40MG TABLET / ORAL AB 1995-11-09 A074501-003 NADOLOL NADOLOL 80MG TABLET / ORAL AB 1995-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 123 observed 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 2026-02-19 14:30 UTC 2026-02 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074501-002 NADOLOL 40MG TABLET / ORAL AB 1995-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074501-003 NADOLOL 80MG TABLET / ORAL AB 1995-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074501-001 NADOLOL 20MG TABLET / ORAL AB 1995-11-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NADOLOL ACTIVE INGREDIENT FEN504330V NADOLOL TABLET [SANDOZ INC] 13 NADOLOL ACTIVE MOIETY FEN504330V NADOLOL TABLET [SANDOZ INC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NADOLOL TABLET [SANDOZ INC] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NADOLOL TABLET [SANDOZ INC] 13 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P NADOLOL TABLET [SANDOZ INC] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NADOLOL TABLET [SANDOZ INC] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NADOLOL TABLET [SANDOZ INC] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NADOLOL TABLET [SANDOZ INC] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NADOLOL TABLET [SANDOZ INC] 13 WATER INACTIVE INGREDIENT 059QF0KO0R NADOLOL TABLET [SANDOZ INC] 13 NADOLOL ACTIVE INGREDIENT FEN504330V NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 NADOLOL ACTIVE INGREDIENT FEN504330V NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 NADOLOL ACTIVE MOIETY FEN504330V NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 NADOLOL ACTIVE MOIETY FEN504330V NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NADOLOL TABLET [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NADOLOL TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#