Tramadol Hydrochloride

Product NDC
68788-4040
11-digit product format
687884040
Labeler code
68788
Product ID
68788-4040_f558c59c-cbd4-4b17-9a3d-b014ad09bbb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211825
Marketing category
ANDA
Marketing start
2025-10-13
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
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 · 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
2026-12-31

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
f558c59c-cbd4-4b17-9a3d-b014ad09bbb1Available 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
68788-4040-1Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
68788-4040-2Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201
68788-4040-3Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68788-4040-4Tramadol Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED401
68788-4040-5Tramadol Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
68788-4040-6Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-4040-7Tramadol Hydrochloride50 in 1 BOTTLE, PLASTICTABLET, FILM COATED501
68788-4040-8Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
68788-4040-9Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4040-1EA - Each68788-404056d3ea0a-36cf-4e91-bb22-78dfa1f64c8c12026-01-08
68788-4040-2EA - Each68788-40409f7dc656-6c27-4988-8c79-049153b3ae9012026-01-08
68788-4040-3EA - Each68788-40405ef13fd9-aba2-4fd7-9730-a76c3cbfb77412026-01-08
68788-4040-4EA - Each68788-4040a4f2b9b9-cd4f-417d-81a1-ba266269e2ea12026-01-08
68788-4040-5EA - Each68788-40407227ae73-b9c4-4926-a7fc-4ef1a001c49b12026-01-08
68788-4040-6EA - Each68788-4040f11736e3-dafb-427c-873c-a2ba8d8b5e4712026-01-08
68788-4040-7EA - Each68788-404019575d96-6094-4a53-961d-91ea28a7ee1d12026-01-08
68788-4040-8EA - Each68788-4040b24cd753-81f2-46b8-8b2d-86f6536aa10312026-01-08
68788-4040-9EA - Each68788-4040850e9165-7be4-4cb0-a988-58e43719f71012026-01-08

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
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
ndc (product): 68788-4040
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 TabletPSNf558c59c-cbd4-4b17-9a3d-b014ad09bbb11
835603tramadol hydrochloride 50 MG Oral TabletSCDf558c59c-cbd4-4b17-9a3d-b014ad09bbb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4040-168788404001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-1) 2025-10-13NoNoCurrent
68788-4040-26878840400220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-2) 2025-10-13NoNoCurrent
68788-4040-36878840400330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-3) 2025-10-13NoNoCurrent
68788-4040-46878840400440 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-4) 2025-10-13NoNoCurrent
68788-4040-56878840400515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-5) 2025-10-13NoNoCurrent
68788-4040-66878840400660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-6) 2025-10-13NoNoCurrent
68788-4040-76878840400750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-7) 2025-10-13NoNoCurrent
68788-4040-868788404008120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-8) 2025-10-13NoNoCurrent
68788-4040-96878840400990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-9) 2025-10-13NoNoCurrent