Home NDC 71610-865 Tramadol Hydrochloride
Product NDC 71610-865
11-digit product format 716100865
Labeler code 71610
Product ID 71610-865_27460b14-190b-94e9-e063-6394a90ae97f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tramadol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075977
Marketing category ANDA
Marketing start 2002-06-19
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075977-001 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 A075977-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tramadol Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAMADOL HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9N7R477WCK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835603 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 71610-865-15 Tramadol Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 1 71610-865-20 Tramadol Hydrochloride 20 in 1 BOTTLE TABLET, FILM COATED 20 1 71610-865-24 Tramadol Hydrochloride 224 in 1 BOTTLE TABLET, FILM COATED 224 1 71610-865-28 Tramadol Hydrochloride 28 in 1 BOTTLE TABLET, FILM COATED 28 1 71610-865-30 Tramadol Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71610-865-40 Tramadol Hydrochloride 40 in 1 BOTTLE TABLET, FILM COATED 40 1 71610-865-45 Tramadol Hydrochloride 45 in 1 BOTTLE TABLET, FILM COATED 45 1 71610-865-46 Tramadol Hydrochloride 56 in 1 BOTTLE TABLET, FILM COATED 56 1 71610-865-50 Tramadol Hydrochloride 50 in 1 BOTTLE TABLET, FILM COATED 50 1 71610-865-53 Tramadol Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71610-865-54 Tramadol Hydrochloride 84 in 1 BOTTLE TABLET, FILM COATED 84 1 71610-865-57 Tramadol Hydrochloride 80 in 1 BOTTLE TABLET, FILM COATED 80 1 71610-865-60 Tramadol Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 1 71610-865-65 Tramadol Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 71610-865-67 Tramadol Hydrochloride 168 in 1 BOTTLE TABLET, FILM COATED 168 1 71610-865-70 Tramadol Hydrochloride 120 in 1 BOTTLE TABLET, FILM COATED 120 1 71610-865-72 Tramadol Hydrochloride 112 in 1 BOTTLE TABLET, FILM COATED 112 1 71610-865-73 Tramadol Hydrochloride 135 in 1 BOTTLE TABLET, FILM COATED 135 1 71610-865-75 Tramadol Hydrochloride 150 in 1 BOTTLE TABLET, FILM COATED 150 1 71610-865-80 Tramadol Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 1 71610-865-85 Tramadol Hydrochloride 200 in 1 BOTTLE TABLET, FILM COATED 200 1 71610-865-90 Tramadol Hydrochloride 240 in 1 BOTTLE TABLET, FILM COATED 240 1 71610-865-92 Tramadol Hydrochloride 270 in 1 BOTTLE TABLET, FILM COATED 270 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-865 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 23 package rows 20241121_27460cc6-0782-7838-e063-6394a90a19f1.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Golden State Medical Supply, Inc. 24aea499-c6f1-9200-e063-6394a90a9db6 2026-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075977 application number: ANDA075977 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 561f00e5-f69c-4369-ae4d-5eff86c4499f 2025-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075977 application number: ANDA075977 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 27460cc6-0782-7838-e063-6394a90a19f1 2024-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075977 application number: ANDA075977 ndc (product): 71610-865 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e 2019-04-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075977 application number: ANDA075977
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-865-15 71610086515 15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15) 2024-11-18 No No Current 71610-865-20 71610086520 20 TABLET, FILM COATED in 1 BOTTLE (71610-865-20) 2024-11-18 No No Current 71610-865-24 71610086524 224 TABLET, FILM COATED in 1 BOTTLE (71610-865-24) 2024-11-18 No No Current 71610-865-28 71610086528 28 TABLET, FILM COATED in 1 BOTTLE (71610-865-28) 2024-11-18 No No Current 71610-865-30 71610086530 30 TABLET, FILM COATED in 1 BOTTLE (71610-865-30) 2024-11-18 No No Current 71610-865-40 71610086540 40 TABLET, FILM COATED in 1 BOTTLE (71610-865-40) 2024-11-18 No No Current 71610-865-45 71610086545 45 TABLET, FILM COATED in 1 BOTTLE (71610-865-45) 2024-11-18 No No Current 71610-865-46 71610086546 56 TABLET, FILM COATED in 1 BOTTLE (71610-865-46) 2024-11-18 No No Current 71610-865-50 71610086550 50 TABLET, FILM COATED in 1 BOTTLE (71610-865-50) 2024-11-18 No No Current 71610-865-53 71610086553 60 TABLET, FILM COATED in 1 BOTTLE (71610-865-53) 2024-11-18 No No Current 71610-865-54 71610086554 84 TABLET, FILM COATED in 1 BOTTLE (71610-865-54) 2024-11-18 No No Current 71610-865-57 71610086557 80 TABLET, FILM COATED in 1 BOTTLE (71610-865-57) 2024-11-18 No No Current 71610-865-60 71610086560 90 TABLET, FILM COATED in 1 BOTTLE (71610-865-60) 2024-11-18 No No Current 71610-865-65 71610086565 100 TABLET, FILM COATED in 1 BOTTLE (71610-865-65) 2024-11-18 No No Current 71610-865-67 71610086567 168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67) 2024-11-18 No No Current 71610-865-70 71610086570 120 TABLET, FILM COATED in 1 BOTTLE (71610-865-70) 2024-11-18 No No Current 71610-865-72 71610086572 112 TABLET, FILM COATED in 1 BOTTLE (71610-865-72) 2024-11-18 No No Current 71610-865-73 71610086573 135 TABLET, FILM COATED in 1 BOTTLE (71610-865-73) 2024-11-18 No No Current 71610-865-75 71610086575 150 TABLET, FILM COATED in 1 BOTTLE (71610-865-75) 2024-11-18 No No Current 71610-865-80 71610086580 180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80) 2024-11-18 No No Current 71610-865-85 71610086585 200 TABLET, FILM COATED in 1 BOTTLE (71610-865-85) 2024-11-18 No No Current 71610-865-90 71610086590 240 TABLET, FILM COATED in 1 BOTTLE (71610-865-90) 2024-11-18 No No Current 71610-865-92 71610086592 270 TABLET, FILM COATED in 1 BOTTLE (71610-865-92) 2024-11-18 No No Current