Tramadol Hydrochloride

Product NDC
29300-355
11-digit product format
293000355
Labeler code
29300
Product ID
29300-355_2e474886-5eb1-4fa0-b53e-04281e31b631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA211825
Marketing category
ANDA
Marketing start
2019-08-09
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211825-001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211825-001AB

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 UTC2026-02A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-093f01610625f2…
2019-09-15 20:21 UTC2019-09A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211825-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORALAB2019-08-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211825-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211825-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211825-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211825-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211825-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211825-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211825-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211825-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211825-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211825-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211825-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211825-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211825-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211825-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211825-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211825-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211825-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211825-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211825-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211825-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211825-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211825-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211825-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211825-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211825-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211825-001AB1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211825-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211825-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211825-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211825-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211825-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211825-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211825-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211825-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211825-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211825-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211825-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211825-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211825-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211825-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 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
835603Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
007bf37f-0e46-426a-ac8c-be63d4b7414cAvailable 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
29300-355-01Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10026
29300-355-05Tramadol Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50026
29300-355-10Tramadol Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-355-01EA - Each29300-35511b04bd0-74ae-4b19-8668-aec66285d13112020-05-08
29300-355-05EA - Each29300-3555536b5e7-dba1-44c7-a4f7-404c204cdb0512020-05-08
29300-355-10EA - Each29300-35514c9dbe2-8373-41f0-9634-1137dc222b6c12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-355TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]17Current NDC, Legacy NDC, 3 package rows20240207_007bf37f-0e46-426a-ac8c-be63d4b7414c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.007bf37f-0e46-426a-ac8c-be63d4b7414c2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825
ndc (product): 29300-355
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEA-S Medication Solutions4a525cf7-2c0c-47c6-aed3-3a395a7120ec2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEA-S Medication Solutionsf9282800-fde7-477a-8b8f-59617ec26f732026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAsclemed USA, Inc.18d9e3e4-5892-43b8-b211-3ef3393ad9462026-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3d719560-7449-f970-e063-6294a90a9bd82025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.f558c59c-cbd4-4b17-9a3d-b014ad09bbb12025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.e6e275c3-1e16-4a00-b7fd-608ae6cbd5152025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211825
application number: ANDA211825

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN007bf37f-0e46-426a-ac8c-be63d4b7414c26
835603tramadol hydrochloride 50 MG Oral TabletSCD007bf37f-0e46-426a-ac8c-be63d4b7414c26
835603traMADol HCl 50 MG Oral TabletPSN4a525cf7-2c0c-47c6-aed3-3a395a7120ec17
835603tramadol hydrochloride 50 MG Oral TabletSCD4a525cf7-2c0c-47c6-aed3-3a395a7120ec17
835603traMADol HCl 50 MG Oral TabletPSNf9282800-fde7-477a-8b8f-59617ec26f7313
835603tramadol hydrochloride 50 MG Oral TabletSCDf9282800-fde7-477a-8b8f-59617ec26f7313
835603traMADol HCl 50 MG Oral TabletPSN3d719560-7449-f970-e063-6294a90a9bd83
835603tramadol hydrochloride 50 MG Oral TabletSCD3d719560-7449-f970-e063-6294a90a9bd83
835603traMADol HCl 50 MG Oral TabletPSN18d9e3e4-5892-43b8-b211-3ef3393ad9461
835603traMADol HCl 50 MG Oral TabletPSNe6e275c3-1e16-4a00-b7fd-608ae6cbd5151
835603traMADol HCl 50 MG Oral TabletPSNf558c59c-cbd4-4b17-9a3d-b014ad09bbb11
835603tramadol hydrochloride 50 MG Oral TabletSCD18d9e3e4-5892-43b8-b211-3ef3393ad9461
835603tramadol hydrochloride 50 MG Oral TabletSCDe6e275c3-1e16-4a00-b7fd-608ae6cbd5151
835603tramadol hydrochloride 50 MG Oral TabletSCDf558c59c-cbd4-4b17-9a3d-b014ad09bbb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-355-0129300035501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-01) 2019-11-040000-00-00NoNoCurrent
29300-355-0529300035505500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-05) 2019-11-040000-00-00NoNoCurrent
29300-355-10293000355101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-355-10) 2019-11-040000-00-00NoNoCurrent