FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
33342-271
11-digit product format
333420271
Labeler code
33342
Product ID
33342-271_0f59cb5b-586f-41de-866f-e2386f4d0178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209404
Marketing category
ANDA
Marketing start
2025-01-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 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
A209404-001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31
A209404-002TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31
A209404-003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209404-001AB1
A209404-002AB1
A209404-003AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209404-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209404-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209404-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209404-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209404-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209404-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209404-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209404-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209404-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209404-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209404-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209404-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209404-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209404-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209404-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209404-001TRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209404-002TRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209404-003TRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB12025-01-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209404-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209404-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209404-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209404-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209404-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209404-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209404-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209404-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209404-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209404-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209404-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209404-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209404-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209404-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209404-003AB11b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209404-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209404-002AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209404-003AB11a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE300 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
833709Internal RxNorm lookup
833711Internal RxNorm lookup
833713Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a07ed444-54e4-4d45-b6a1-6ea2f6dedc61Available 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
33342-271-07Tramadol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
33342-271-10Tramadol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
33342-271-11Tramadol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-271-07EA - Each33342-271952784bd-f661-481d-b1fe-d13656e97c8f12025-12-16

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPaefc85bc-0820-4aee-8d94-313c5f1658f52026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209404
application number: ANDA209404
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda07ed444-54e4-4d45-b6a1-6ea2f6dedc612025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209404
application number: ANDA209404
ndc (product): 33342-271

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSNa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSYa07ed444-54e4-4d45-b6a1-6ea2f6dedc614
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYa07ed444-54e4-4d45-b6a1-6ea2f6dedc614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-271-073334202710730 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-07) 2025-01-31NoNoCurrent
33342-271-103334202711090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-10) 2025-01-31NoNoCurrent
33342-271-1133342027111100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-11) 2025-01-31NoNoCurrent