Home NDC 72189-406 HYDROCODONE/APAP
Product NDC 72189-406
11-digit product format 721890406
Labeler code 72189
Product ID 72189-406_2c4cdc9e-f775-a44a-e063-6294a90a3c96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCODONE/APAP
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA040405
Marketing category ANDA
Marketing start 2022-12-15
Substance ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength 325; 7.5 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-406-60 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-406-30 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-406-90 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-406-60 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-406-30 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-406-90 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040405-001 ANEXSIA 7.5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040405-001 AA
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 2 · 41 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 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA 2000-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040405-001 ANEXSIA 7.5/325 325MG;7.5MG TABLET / ORAL AA RS 2000-09-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base HYDROCODONE/APAP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCODONE BITARTRATE 325 mg/1 ACETAMINOPHEN 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NO70W886KK Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857005 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 72189-406-30 HYDROCODONE/APAP 30 in 1 BOTTLE TABLET 30 7 72189-406-60 HYDROCODONE/APAP 60 in 1 BOTTLE TABLET 60 7 72189-406-90 HYDROCODONE/APAP 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-406 HYDROCODONE/APAP TABLET [DIRECT_RX] 7 Current NDC, Legacy NDC, 3 package rows 20250123_efe3b2eb-5c26-3783-e053-2995a90a6ba8.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 · 2 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 72189-406-30 72189040630 30 TABLET in 1 BOTTLE (72189-406-30) 30 tablet 2022-12-15 No No Current 72189-406-60 72189040660 60 TABLET in 1 BOTTLE (72189-406-60) 60 tablet 2022-12-15 No No Current 72189-406-90 72189040690 90 TABLET in 1 BOTTLE (72189-406-90) 90 tablet 2022-12-15 0000-00-00 No No Current