Application 090200

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL500MGNoNo
002METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL750MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090200-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2009-11-06
A090200-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2009-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090200-001AA
A090200-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090200-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090200-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090200-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090200-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090200-002AA1782e0a99824c…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLAmerican Health Packagingd842fe4e-fc46-4d70-9ca3-b47191672f962026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLUnit Dose Solutions, Inc.5539d4f6-1192-2770-e063-6394a90a1e502026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAvPAKbe37bc85-6a41-00d8-e053-2a95a90ae5042026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCf31ccb09-7a9a-60af-e053-2995a90a6e972026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCdf63611f-90e4-6bbe-e053-2a95a90a2aad2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC18810520-3040-4802-e063-6294a90a1ec02025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCardinal Health 107, LLC05b287d3-5004-4d8b-9ebe-a96caa2b8d892025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9aed8304-fa4e-49d6-bd81-fcb3e4cc61732025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsff55df39-e314-4120-8fab-3757cbe5a8722025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions069045f1-d699-41d0-b674-cdb71cd5fbd02025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.eed9ebd1-c243-4e82-bf4e-5fec370e722e2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCoupler LLC2cee3893-70b7-6c2c-e063-6394a90aa79a2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf4e98f9f-b20b-8608-e053-2a95a90aa6b02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f47c39b-9373-454f-9a4e-ba6dd65dd7a42024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (product): 71335-0251
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackadd9e47f-11ac-e10d-bfc2-b9c52aa08fa52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (product): 63629-1622
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.9d6024b2-ee1a-3a79-e053-2a95a90a1bf42024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (product): 66267-803
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.3e89a426-c741-2f44-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (product): 66267-146
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC1880efb2-b97e-1e4d-e063-6294a90ab3e32024-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLXLCare Pharmaceuticals Inc.f8bfb5cb-b7d0-4e09-b6bd-97a51d82c9912024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 133 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-1622MethocarbamolMethocarbamolBryant Ranch PrepackANDACurrent
63629-1622MethocarbamolMethocarbamolBryant Ranch PrepackANDACurrent
63629-8097MethocarbamolMethocarbamolBryant Ranch PrepackANDACurrent
65977-5033MethocarbamolMethocarbamolHetero Drugs Limited Unit IIIANDACurrent
65977-5034MethocarbamolMethocarbamolHetero Drugs Limited Unit IIIANDACurrent
66267-145MethocarbamolMethocarbamolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-145MethocarbamolMethocarbamolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-146MethocarbamolMethocarbamolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-146MethocarbamolMethocarbamolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-803MethocarbamolMethocarbamolNuCare Pharmaceuticals,Inc.ANDACurrent
66267-803MethocarbamolMethocarbamolNuCare Pharmaceuticals,Inc.ANDACurrent
67046-467MethocarbamolMethocarbamolContract Pharmacy Services-PAANDACurrent
67296-0751MethocarbamolMethocarbamolRedPharm Drug, Inc.ANDACurrent
67296-0751MethocarbamolMethocarbamolRedPharm Drug, Inc.ANDACurrent
67296-1049MethocarbamolMethocarbamolRedPharm Drug, Inc.ANDACurrent
67296-1049MethocarbamolMethocarbamolRedPharm Drug, Inc.ANDACurrent
67296-1049MethocarbamolMethocarbamolRedPharm Drug, Inc.ANDACurrent
68084-056MethocarbamolMethocarbamolAmerican Health PackagingANDACurrent
68084-057MethocarbamolMethocarbamolAmerican Health PackagingANDACurrent
68788-6391MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6391MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6391MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6391MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9376MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9376MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9376MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9376MethocarbamolMethocarbamolPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0536MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-0536MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-0548MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-0548MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-0548MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1271MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1271MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1271MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1554MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1554MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1554MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1554MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70518-1554MethocarbamolMethocarbamolREMEDYREPACK INC.ANDACurrent
70934-114MethocarbamolMethocarbamolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-114MethocarbamolMethocarbamolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0251MethocarbamolMethocarbamolBryant Ranch PrepackANDACurrent
71335-0251MethocarbamolMethocarbamolBryant Ranch PrepackANDACurrent
71335-0251MethocarbamolMethocarbamolBryant Ranch PrepackANDACurrent
80175-0533METHCARBAMOLMETHCARBAMOLCentral PackagingANDACurrent
80175-0533METHCARBAMOLMETHCARBAMOLCentral PackagingANDACurrent
80175-0533METHCARBAMOLMETHCARBAMOLCentral PackagingANDACurrent
80175-0533METHCARBAMOLMETHCARBAMOLCentral PackagingANDACurrent
80175-0534METHOCARBAMOLMETHOCARBAMOLCentral PackagingANDACurrent
80175-0534METHOCARBAMOLMETHOCARBAMOLCentral PackagingANDACurrent
80175-0534METHOCARBAMOLMETHOCARBAMOLCentral PackagingANDACurrent
80175-0534METHOCARBAMOLMETHOCARBAMOLCentral PackagingANDACurrent