Home NDC 0093-3301 Tramadol Hydrochloride
Product NDC 0093-3301
11-digit product format 000933301
Labeler code 0093
Product ID 0093-3301_502158c7-0bbc-4818-aa36-c6532bde9110
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tramadol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA075977
Marketing category ANDA
Marketing start 2024-09-12
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 · 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A075977-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075977-001 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.
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 0093-3301-01 Tramadol Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 6 0093-3301-05 Tramadol Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-3301 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 4 Current NDC, 2 package rows 20240919_561f00e5-f69c-4369-ae4d-5eff86c4499f.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 ndc (product): 0093-3301 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 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 0093-3301-01 00093330101 100 TABLET, FILM COATED in 1 BOTTLE (0093-3301-01) 2024-09-17 No No Current 0093-3301-05 00093330105 500 TABLET, FILM COATED in 1 BOTTLE (0093-3301-05) 2024-09-12 No No Current