Home NDC 0245-0144 Pacerone
Product NDC 0245-0144
11-digit product format 002450144
Labeler code 0245
Product ID 0245-0144_39e7666b-4916-2716-e063-6394a90a0589
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA075135
Marketing category ANDA
Marketing start 2010-11-15
Substance AMIODARONE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075135-001 PACERONE AMIODARONE HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-04-30 A075135-002 PACERONE AMIODARONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-04-12 A075135-003 PACERONE AMIODARONE HYDROCHLORIDE 400MG TABLET / ORAL AB 2020-07-02
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 · 121 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 2026-08-18 06:07:40 2026-07 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075135-002 PACERONE 100MG TABLET / ORAL AB 2005-04-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075135-003 PACERONE 400MG TABLET / ORAL AB 2020-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075135-001 PACERONE 200MG TABLET / ORAL AB 1998-04-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pacerone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIODARONE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 976728SY6Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833528 Internal RxNorm lookup 834346 Internal RxNorm lookup 834348 Internal RxNorm lookup 834350 Internal RxNorm lookup 835956 Internal RxNorm lookup 835958 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0245-0144-01 Pacerone 100 in 1 CARTON TABLET 100 27 0245-0144-11 Pacerone 100 in 1 BOTTLE TABLET 100 27 0245-0144-30 Pacerone 30 in 1 BOTTLE TABLET 30 27 0245-0144-89 Pacerone 1 in 1 BLISTER PACK TABLET 1 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amiodarone Hydrochloride ACTIVE INGREDIENT 976728SY6Z PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 Amiodarone ACTIVE MOIETY N3RQ532IUT PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 magnesium stearate INACTIVE INGREDIENT 70097M6I30 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 povidones INACTIVE INGREDIENT FZ989GH94E PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 starch, corn INACTIVE INGREDIENT O8232NY3SJ PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0144 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, LLC] 26 Current NDC, Legacy NDC, 4 package rows 20230602_4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pacerone AMIODARONE HYDROCHLORIDE Bryant Ranch Prepack dcadce9c-d0a0-4235-8ff8-dd93c09e03b3 2025-11-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075135 application number: ANDA075135 Pacerone AMIODARONE HYDROCHLORIDE Upsher-Smith Laboratories, LLC 4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7 2025-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075135 application number: ANDA075135 ndc (product): 0245-0144 Pacerone AMIODARONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 02f4a736-63ed-4ad4-a1f1-b21a71e928bd 2024-02-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075135 application number: ANDA075135
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 0245-0144-01 00245014401 100 BLISTER PACK in 1 CARTON (0245-0144-01) / 1 TABLET in 1 BLISTER PACK (0245-0144-89) 100 blister pack 2011-01-19 0000-00-00 No No Current 0245-0144-11 00245014411 100 TABLET in 1 BOTTLE (0245-0144-11) 100 tablet 2011-01-19 0000-00-00 No No Current 0245-0144-30 00245014430 30 TABLET in 1 BOTTLE (0245-0144-30) 30 tablet 2011-01-19 0000-00-00 No No Current 0245-0144-89 00245014489 1 in 1 BLISTER PACK Historical