FDA.reportPublic FDA data

Application 209312

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL500MGNoYes
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
A209312-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAARS2018-05-07
A209312-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAARS2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209312-001AA
A209312-002AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07a50c72e98297…
2026-08-01 22:54:322026-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209312-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A209312-002AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.52b20439-6bf4-435e-817a-c3b3fc70846a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 70518-1723
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.37767123-8b72-4e1f-b00d-ff3305e9923f2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSUnit Dose Solutions, Inc.561ae476-9e1f-038a-e063-6394a90aa5c72026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSGranules Pharmaceuticals Inc.6f0d3966-962d-fa7c-e053-2a91aa0a8e3c2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 70010-770
ndc (product): 70010-754
MethocarbamolMETHOCARBAMOL TABLETSBryant Ranch Prepack65c460f6-6470-41ff-abb4-d9d54ecc52f72026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacy7d4dd78a-f902-6ff2-e053-2991aa0ac7d72026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 60760-770
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.43f83b87-e169-46fe-98bd-6af373595bd32026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 68788-8172
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.e03878d3-d780-4e7f-b828-20ac2a1099332026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 68788-8213
MethocarbamolMETHOCARBAMOL TABLETSCoupler LLC52b87514-e6e0-ab57-e063-6394a90a6b232026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.71c21226-cd96-33ed-e053-2995a90a52692026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 68071-4505
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacyfaa81ad3-2bd2-d637-e053-6294a90a2d362026-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSProficient Rx LP23163bc1-dec7-41f6-baed-eedebfd6be7e2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.1dc3a5b1-c83b-406b-a59d-ce8075e4ccf92026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4de118fe-bd8e-6cc4-e063-6394a90a13202026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4cefe51c-d824-a862-e063-6394a90a77172026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSRedpharm Drug44f264fd-bf40-bed9-e063-6294a90ac44a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.72f36d28-15d2-30f6-e053-2a91aa0ad1ce2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 68071-4520
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed95-0469-393a-e053-2a95a90a98ed2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (product): 61919-616
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed5f-3489-9ee4-e053-2995a90a25f02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-413MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
35573-414MethocarbamolMethocarbamolBurel Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, InANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-903MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, InANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-905MethocarbamolMethocarbamol TabletsPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3556MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3556MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3556MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3557MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3557MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3557MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3570MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3570MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50090-3570MethocarbamolMethocarbamol TabletsA-S Medication SolutionsANDACurrent
50436-0770MethocarbamolMethocarbamol TabletsUnit Dose ServicesANDACurrent
53002-3591MethocarbamolMethocarbamol TabletsRPK Pharmaceuticals, Inc.ANDACurrent
60760-770MethocarbamolMethocarbamol TabletsSt. Mary's Medical Park PharmacyANDACurrent
60760-770MethocarbamolMethocarbamol TabletsSt. Mary's Medical Park PharmacyANDACurrent
60760-770MethocarbamolMethocarbamol TabletsSt. Mary's Medical Park PharmacyANDACurrent
61919-610MethocarbamolMethocarbamolDirectRXANDACurrent
61919-610MethocarbamolMethocarbamolDirectRXANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-610MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDirect_RxANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
61919-616MethocarbamolMethocarbamolDIRECT RXANDACurrent
62207-754MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-754MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-754MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-770MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-770MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
62207-770MethocarbamolMethocarbamol TabletsGranules India LtdANDACurrent
63739-991MethocarbamolMethocarbamol TabletsMcKesson Corporation dba SKY PackagingANDACurrent
63739-992MethocarbamolMethocarbamol TabletsMcKesson Corporation dba SKY PackagingANDACurrent
67046-538MethocarbamolMethocarbamol TabletsContract Pharmacy Services-PAANDACurrent
68071-2867MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4505MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4520MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4520MethocarbamolMethocarbamol TabletsNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8172MethocarbamolMethocarbamol TabletsPreferred Pharmaceuticals Inc.ANDACurrent
68788-8213MethocarbamolMethocarbamol TabletsPreferred Pharmaceuticals Inc.ANDACurrent
70010-754MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-754MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-754MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-770MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-770MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70010-770MethocarbamolMethocarbamol TabletsGranules Pharmaceuticals Inc.ANDACurrent
70518-1723MethocarbamolMethocarbamol TabletsREMEDYREPACK INC.ANDACurrent