Home NDC 76420-105 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product NDC 76420-105
11-digit product format 764200105
Labeler code 76420
Product ID 76420-105_b2ddcdd0-7229-99df-e053-2a95a90a8818
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA201952
Marketing category ANDA
Marketing start 2012-12-15
Substance ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength 325; 37.5 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CIV
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 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 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET / ORAL 2012-12-14
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 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201952-001 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG TABLET / ORAL AB 2012-12-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAMADOL HYDROCHLORIDE 325 mg/1 ACETAMINOPHEN 37.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9N7R477WCK 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 836395 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 76420-105-01 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 1 in 1 BOTTLE TABLET, FILM COATED 1 1 76420-105-02 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 2 in 1 BOTTLE TABLET, FILM COATED 2 1 76420-105-03 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 3 in 1 BOTTLE TABLET, FILM COATED 3 1 76420-105-10 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 10 in 1 BOTTLE TABLET, FILM COATED 10 1 76420-105-30 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-105 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, FILM COATED [ASCLEMED USA, INC.] 1 Current NDC, Legacy NDC, 5 package rows 20201104_82d8b70f-aebf-4b9a-89b1-183fc9e2ff59.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 Marketing start Marketing end Sample Exclude flag Status 76420-105-01 76420010501 1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01) 2020-10-30 0000-00-00 No No Current 76420-105-02 76420010502 2 TABLET, FILM COATED in 1 BOTTLE (76420-105-02) 2020-10-30 0000-00-00 No No Current 76420-105-03 76420010503 3 TABLET, FILM COATED in 1 BOTTLE (76420-105-03) 2020-10-30 0000-00-00 No No Current 76420-105-10 76420010510 10 TABLET, FILM COATED in 1 BOTTLE (76420-105-10) 2020-10-30 0000-00-00 No No Current 76420-105-30 76420010530 30 TABLET, FILM COATED in 1 BOTTLE (76420-105-30) 2020-10-30 0000-00-00 No No Current