TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
57664-537
11-digit product format
576640537
Labeler code
57664
Product ID
57664-537_0aec7684-04b3-485d-a030-3ca9843d097f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077184
Marketing category
ANDA
Marketing start
2005-12-16
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-537DDiscontinued by firm2026-10-05
excluded packagepackage57664-53757664-537-13DDiscontinued by firm2026-10-05
excluded packagepackage57664-53757664-537-18DDiscontinued by firm2026-10-05
excluded packagepackage57664-53757664-537-88DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-537-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-537-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-537-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-537-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-537-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-537-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-537-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-537-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-537-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-537-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-537-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-537-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-537-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-537-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-537-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-537-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-537-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-537-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-537-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-537-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-537-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-537-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-537-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-537-18ed331223b511…672a5bd82f5f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDE325MG;37.5MGTABLET / ORAL2005-12-16

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-1684e616aacf4f…
2026-08-18 06:07:402026-07A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2005-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077184-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORALAB2005-12-16f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077184-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077184-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077184-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077184-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077184-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077184-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077184-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077184-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077184-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077184-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077184-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077184-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077184-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077184-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077184-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077184-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077184-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077184-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077184-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077184-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077184-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077184-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077184-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077184-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077184-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077184-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077184-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077184-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077184-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077184-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-537-13EA - Each57664-537011af264-5329-4815-8f45-2df84c784cef12012-07-24
57664-537-18EA - Each57664-53754f2dc2c-6fe9-45bf-ac52-0bf4d52e307b12012-07-24
57664-537-88EA - Each57664-5371d904019-70d6-42ba-8910-dfe1221b015d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [STAT RX USA LLC]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNea9cc585-c70d-4d82-be02-7b7fe7153cdd8
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDea9cc585-c70d-4d82-be02-7b7fe7153cdd8
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYea9cc585-c70d-4d82-be02-7b7fe7153cdd8
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSN62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce4
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCD62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce4
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSY62be65c6-8c8a-4c29-ae6e-1f1a5b89d1ce4
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNe5914c36-ff79-4fad-b454-4414443cc2303
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDe5914c36-ff79-4fad-b454-4414443cc2303
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYe5914c36-ff79-4fad-b454-4414443cc2303
836395traMADol HCl 37.5 MG / acetaminophen 325 MG Oral TabletPSNe8a55896-67f8-3d23-e053-2a95a90a654a1
836395acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSCDe8a55896-67f8-3d23-e053-2a95a90a654a1
836395APAP 325 MG / tramadol hydrochloride 37.5 MG Oral TabletSYe8a55896-67f8-3d23-e053-2a95a90a654a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-537-1357664053713500 TABLET, FILM COATED in 1 BOTTLE (57664-537-13) 2005-12-160000-00-00NoNoCurrent
57664-537-18576640537181000 TABLET, FILM COATED in 1 BOTTLE (57664-537-18) 2005-12-160000-00-00NoNoCurrent
57664-537-8857664053788100 TABLET, FILM COATED in 1 BOTTLE (57664-537-88) 2005-12-160000-00-00NoNoCurrent