Home NDC 40032-357-10 Hydrocodone Bitartrate and Acetaminophen
Product NDC 40032-357
Requested package NDC 40032-357-10
11-digit product format 400320357
Labeler code 40032
Product ID 40032-357_102fbf8d-aff3-4f1c-b75b-deb9e4e22329
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA206245
Marketing category ANDA
Marketing start 2016-12-01
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength 8 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CII
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL 2016-12-01 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL 2016-12-01 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET / ORAL 2016-12-01
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 · 129 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 2026-09-14 22:38:34 2026-08 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206245-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2016-12-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206245-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2016-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206245-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2016-12-01 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 40032-357-01 Hydrocodone Bitartrate and Acetaminophen 100 in 1 BOTTLE TABLET 100 10 40032-357-03 Hydrocodone Bitartrate and Acetaminophen 30 in 1 BOTTLE TABLET 30 10 40032-357-05 Hydrocodone Bitartrate and Acetaminophen 500 in 1 BOTTLE TABLET 500 10 40032-357-10 Hydrocodone Bitartrate and Acetaminophen 1000 in 1 BOTTLE TABLET 1000 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-357 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NOVEL LABORATORIES, INC.] 10 Legacy NDC, 4 package rows 20191221_7a89f126-9092-42f9-b048-94454d66302c.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 · 1 matching rows.
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 40032-357-10 40032035710 1000 TABLET in 1 BOTTLE (40032-357-10) 1000 tablet 2016-12-01 0000-00-00 No No Current