Home NDC 67296-1021-1 tramadol hydrochloride
Product NDC 67296-1021
Requested package NDC 67296-1021-1
11-digit product format 672961021
Labeler code 67296
Product ID 67296-1021_1cfead90-c8e9-3bb3-e063-6394a90a1090
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tramadol hydrochloride
Dosage form TABLET
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA075964
Marketing category ANDA
Marketing start 2002-06-22
Substance TRAMADOL HYDROCHLORIDE
Active strength 50 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 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 · 5 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 2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A075964-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075964-001 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 · 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 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 67296-1021-1 tramadol hydrochloride 10 in 1 BOTTLE TABLET 10 5 67296-1021-2 tramadol hydrochloride 20 in 1 BOTTLE TABLET 20 5 67296-1021-3 tramadol hydrochloride 30 in 1 BOTTLE TABLET 30 5 67296-1021-4 tramadol hydrochloride 45 in 1 BOTTLE TABLET 45 5 67296-1021-5 tramadol hydrochloride 15 in 1 BOTTLE TABLET 15 5 67296-1021-6 tramadol hydrochloride 6 in 1 BOTTLE TABLET 6 5 67296-1021-7 tramadol hydrochloride 40 in 1 BOTTLE TABLET 40 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1021 TRAMADOL HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.] 5 Current NDC, Legacy NDC, 7 package rows 20240712_4e2c0893-6faf-15ed-e054-00144ff8d46c.zip
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 67296-1021-1 67296102101 10 TABLET in 1 BOTTLE (67296-1021-1) 10 tablet 2002-06-22 0000-00-00 No No Current