Tramadol HCL

Product NDC
80425-0141
11-digit product format
804250141
Labeler code
80425
Product ID
80425-0141_2788965f-0f89-08b5-e063-6394a90a902b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol HCL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201384-001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-07
A201384-002TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-07
A201384-003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-07

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2011-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2011-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2011-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12011-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12011-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12011-12-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12011-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12011-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201384-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12011-12-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201384-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12011-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201384-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12011-12-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201384-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201384-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201384-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201384-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201384-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201384-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201384-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201384-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201384-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201384-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201384-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201384-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201384-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201384-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201384-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201384-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201384-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201384-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201384-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201384-002AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201384-003AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201384-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201384-002AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201384-003AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201384-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201384-002AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201384-003AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201384-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201384-002AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201384-003AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201384-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201384-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201384-003AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201384-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201384-002AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201384-003AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201384-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A201384-002AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A201384-003AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201384-001AB1187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol HCL
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9N7R477WCKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
833709Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c197f4e4-9ea5-562b-e053-2a95a90a975cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0141-1Tramadol HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE308
80425-0141-2Tramadol HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE608
80425-0141-3Tramadol HCLER90 in 1 BOTTLETABLET, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0141-1EA - Each80425-0141fa90fe3d-d6ee-4b53-b948-e0ba90737cea12023-03-13
80425-0141-2EA - Each80425-0141c6054659-dca5-4e2e-b2b7-10fc839ecb5b12023-03-13
80425-0141-3EA - Each80425-014146ba148a-296e-44a3-80fc-6ad449bab8b812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0141TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20241124_c197f4e4-9ea5-562b-e053-2a95a90a975c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack66359f41-9999-4cb8-b632-1fe2ec1e60b22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack43fe10b2-17a4-4dc2-9a48-2378547b61fd2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepacka77b0dba-8ac7-418a-b435-16a0e6c228042026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.004de5a4-80f8-4040-a6ea-be5e99352a362025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCc197f4e4-9ea5-562b-e053-2a95a90a975c2024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
ndc (product): 80425-0141
TRAMADOL HCL ERTRAMADOL HCLDIRECT RX5285f056-c32c-4e7a-bec6-3a726aa23d5a2024-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP00b7f61b-5173-43e6-a3f9-d2efbda40c192022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.dce0d21e-e4c2-4875-a2ce-9d53df190b802022-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP27495d02-8641-4c92-b5a3-edf50abc2a6f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LP68646295-49b2-45ac-bf19-99bb91f7333d2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201384
application number: ANDA201384

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNc197f4e4-9ea5-562b-e053-2a95a90a975c8
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDc197f4e4-9ea5-562b-e053-2a95a90a975c8
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYc197f4e4-9ea5-562b-e053-2a95a90a975c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0141-18042501410130 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0141-1) 2011-12-120000-00-00NoNoCurrent
80425-0141-28042501410260 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0141-2) 2011-12-120000-00-00NoNoCurrent
80425-0141-38042501410390 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0141-3) 2024-11-21NoNoCurrent