Home NDC 55700-412 TRAMADOL HYDROCHLORIDE
Product NDC 55700-412
11-digit product format 557000412
Labeler code 55700
Product ID 55700-412_3f6d04e5-6620-49a4-95f5-03cd9d6f0ecb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tramadol hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
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 No
Listing certified through 2021-12-31
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 3 · 165 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 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…2022-10-28 04:53 UTC 2022-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 55700-412-01 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-12 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-15 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-18 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-20 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-24 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-30 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-40 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-60 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-90 2025-01-09 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-01 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-12 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-15 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-18 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-20 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-24 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-30 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-40 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-60 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV 55700-412-90 2023-01-30 TRAMADOL HYDROCHLORIDE - Tramadol Hydrochloride Tablets, USP CIV
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55700-412-01 55700041201 120 TABLET, FILM COATED in 1 BOTTLE (55700-412-01) 2016-06-03 0000-00-00 No No Current 55700-412-12 55700041212 12 TABLET, FILM COATED in 1 BOTTLE (55700-412-12) 2016-06-03 0000-00-00 No No Current 55700-412-15 55700041215 15 TABLET, FILM COATED in 1 BOTTLE (55700-412-15) 2016-06-03 0000-00-00 No No Current 55700-412-18 55700041218 180 TABLET, FILM COATED in 1 BOTTLE (55700-412-18) 2016-06-03 0000-00-00 No No Current 55700-412-20 55700041220 20 TABLET, FILM COATED in 1 BOTTLE (55700-412-20) 2016-06-03 0000-00-00 No No Current 55700-412-24 55700041224 240 TABLET, FILM COATED in 1 BOTTLE (55700-412-24) 2016-06-03 0000-00-00 No No Current 55700-412-30 55700041230 30 TABLET, FILM COATED in 1 BOTTLE (55700-412-30) 2016-06-03 0000-00-00 No No Current 55700-412-40 55700041240 40 TABLET, FILM COATED in 1 BOTTLE (55700-412-40) 2016-06-03 0000-00-00 No No Current 55700-412-60 55700041260 60 TABLET, FILM COATED in 1 BOTTLE (55700-412-60) 2016-06-03 0000-00-00 No No Current 55700-412-90 55700041290 90 TABLET, FILM COATED in 1 BOTTLE (55700-412-90) 2016-06-03 0000-00-00 No No Current