Home NDC 67296-1329 TRAMADOL HYDROCHLORIDE
Product NDC 67296-1329
11-digit product format 672961329
Labeler code 67296
Product ID 67296-1329_502297e7-8ece-3315-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAMADOL HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA091498
Marketing category ANDA
Marketing start 2015-05-22
Marketing end 0000-00-00
Substance TRAMADOL HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CIV
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A091498-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091498-001 AB
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 · 44 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 2026-10-15 13:18:30 2026-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A091498-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091498-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091498-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091498-001 AB 1 a50c72e98297…
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 67296-1329-1 TRAMADOL HYDROCHLORIDE 10 in 1 BOTTLE TABLET 10 1 67296-1329-3 TRAMADOL HYDROCHLORIDE 30 in 1 BOTTLE TABLET 30 1 67296-1329-5 TRAMADOL HYDROCHLORIDE 15 in 1 BOTTLE TABLET 15 1 67296-1329-6 TRAMADOL HYDROCHLORIDE 6 in 1 BOTTLE TABLET 6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1329 TRAMADOL HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.] 1 Legacy NDC, 4 package rows 20170523_502297e7-8ecd-3315-e054-00144ff8d46c.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 Status 67296-1329-1 67296132901 10 in 1 BOTTLE Historical 67296-1329-3 67296132903 30 in 1 BOTTLE Historical 67296-1329-5 67296132905 15 in 1 BOTTLE Historical 67296-1329-6 67296132906 6 in 1 BOTTLE Historical