Home NDC 60760-727 Tramadol Hydrochloride
Product NDC 60760-727
11-digit product format 607600727
Labeler code 60760
Product ID 60760-727_4b9860c4-208c-30bc-e063-6294a90a5b71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tramadol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler ST. MARY'S MEDICAL PARK PHARMACY
Application ANDA075968
Marketing category ANDA
Marketing start 2024-08-05
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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075968-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-25 A075968-002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 53 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 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075968-002 TRAMADOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075968-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL 2002-06-25 1c564ffb4f44…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tramadol Hydrochloride
Listing expiration 2027-12-31 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 60760-727-09 Tramadol Hydrochloride 9 in 1 BOTTLE, PLASTIC TABLET 9 6 60760-727-20 Tramadol Hydrochloride 20 in 1 BOTTLE, PLASTIC TABLET 20 6 60760-727-30 Tramadol Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 6 60760-727-50 Tramadol Hydrochloride 50 in 1 BOTTLE, PLASTIC TABLET 50 6 60760-727-60 Tramadol Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET 60 6 60760-727-90 Tramadol Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 6 60760-727-92 Tramadol Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET 120 6 60760-727-98 Tramadol Hydrochloride 180 in 1 BOTTLE, PLASTIC TABLET 180 6
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE St. Mary's Medical Park Pharmacy 42de8c3a-0441-5d46-e063-6294a90a2079 2026-07-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075968 application number: ANDA075968 ndc (product): 60760-727 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Advanced Rx of Tennessee, LLC 552e5b32-accf-29dd-e063-6294a90a4fcf 2026-06-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075968 application number: ANDA075968 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Bryant Ranch Prepack 515baa9a-b226-4bbe-be87-f9befdf1c9e1 2026-06-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075968 application number: ANDA075968 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Preferred Pharmaceuticals Inc. 855905c7-1481-4b2d-a318-3254ad8ed73c 2026-06-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075968 application number: ANDA075968 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Rising Pharma Holdings, Inc. b5852b90-e415-47ef-8f73-87266b58e033 2026-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075968 application number: ANDA075968
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60760-727-09 60760072709 9 TABLET in 1 BOTTLE, PLASTIC (60760-727-09) 9 tablet 2026-02-23 No No Current 60760-727-20 60760072720 20 TABLET in 1 BOTTLE, PLASTIC (60760-727-20) 20 tablet 2025-11-13 No No Current 60760-727-30 60760072730 30 TABLET in 1 BOTTLE, PLASTIC (60760-727-30) 30 tablet 2025-11-05 No No Current 60760-727-50 60760072750 50 TABLET in 1 BOTTLE, PLASTIC (60760-727-50) 50 tablet 2025-11-05 No No Current 60760-727-60 60760072760 60 TABLET in 1 BOTTLE, PLASTIC (60760-727-60) 60 tablet 2025-12-29 No No Current 60760-727-90 60760072790 90 TABLET in 1 BOTTLE, PLASTIC (60760-727-90) 90 tablet 2025-11-05 No No Current 60760-727-92 60760072792 120 TABLET in 1 BOTTLE, PLASTIC (60760-727-92) 120 tablet 2026-02-16 No No Current 60760-727-98 60760072798 180 TABLET in 1 BOTTLE, PLASTIC (60760-727-98) 180 tablet 2026-02-16 No No Current