Home NDC 16571-716 Tramadol Hydrochloride
Product NDC 16571-716
11-digit product format 165710716
Labeler code 16571
Product ID 16571-716_0803af00-9ccd-46e7-b1f6-571ce6674049
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tramadol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA203494
Marketing category ANDA
Marketing start 2020-09-23
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 A203494-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203494-001 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 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203494-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2014-03-31 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 16571-716-01 Tramadol Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 7 16571-716-10 Tramadol Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 16571-716-50 Tramadol Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-716 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20240316_a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3.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 ST. MARY'S MEDICAL PARK PHARMACY f2f421ab-35ae-7637-e053-2995a90a40e0 2026-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203494 application number: ANDA203494 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Rising Pharma Holdings, Inc. a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3 2026-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203494 application number: ANDA203494 ndc (product): 16571-716 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Aurobindo Pharma Limited e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f 2025-11-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203494 application number: ANDA203494 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE Proficient Rx LP e90d4ef3-8b90-41b7-bf96-340852e89b5f 2024-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203494 application number: ANDA203494
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16571-716-01 16571071601 100 TABLET, FILM COATED in 1 BOTTLE (16571-716-01) 2020-09-23 0000-00-00 No No Current 16571-716-10 16571071610 1000 TABLET, FILM COATED in 1 BOTTLE (16571-716-10) 2020-09-23 0000-00-00 No No Current 16571-716-50 16571071650 500 TABLET, FILM COATED in 1 BOTTLE (16571-716-50) 2020-09-23 0000-00-00 No No Current