Home NDC 67544-570-30 Pacerone
Product NDC 67544-570
Requested package NDC 67544-570-30
11-digit product format 675440570
Labeler code 67544
Product ID 67544-570_a77aeba2-5b50-43d0-8427-f02da6f614b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiodarone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075135
Marketing category ANDA
Marketing start 2011-01-19
Marketing end 0000-00-00
Substance AMIODARONE HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67544-570-30 Pacerone 30 in 1 BOTTLE, PLASTIC TABLET 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amiodarone Hydrochloride ACTIVE INGREDIENT 976728SY6Z PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Amiodarone ACTIVE MOIETY N3RQ532IUT PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 povidones INACTIVE INGREDIENT FZ989GH94E PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-570 PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 4 Legacy NDC, 1 package rows 20191227_2eceb4d5-0c47-49c3-8263-46f689388efe.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 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 67544-570-30 67544057030 30 TABLET in 1 BOTTLE, PLASTIC (67544-570-30) 30 tablet 2011-01-20 0000-00-00 No No Current