Home NDC 55700-598-90 Hydrocodone Bitartrate and Acetaminophen
Product NDC 55700-598
Requested package NDC 55700-598-90
11-digit product format 557000598
Labeler code 55700
Product ID 55700-598_8a8957ac-ad7a-4de3-9e28-70b68cf7652f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA209037
Marketing category ANDA
Marketing start 2018-04-13
Marketing end 0000-00-00
Substance ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength 325 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
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 · 9 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…
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 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL AA 2017-06-21 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL AA 2017-06-21 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET / ORAL AA 2017-06-21
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 · 126 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 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209037-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2017-06-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209037-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2017-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209037-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2017-06-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55700-598-90 55700059890 90 TABLET in 1 BOTTLE (55700-598-90) 90 tablet 2018-04-13 0000-00-00 No No Current