SUNLINDAC

Product NDC
61919-211
11-digit product format
619190211
Labeler code
61919
Product ID
61919-211_9cad4d33-4565-89e0-e053-2a95a90a0cb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULINDAC
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA072051
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
SULINDAC
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-211DDiscontinued by firm2026-08-17
excluded packagepackage61919-21161919-211-30DDiscontinued by firm2026-08-17

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-211-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-211-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-211-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-211-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-211-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-211-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-211-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-211-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-211-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-211-30DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-211-30DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-211-30DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-211-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A072051-001SULINDACSULINDAC200MGTABLET / ORALAB1991-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072051-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A072051-001SULINDAC200MGTABLET / ORALAB1991-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072051-001SULINDAC200MGTABLET / ORALAB1991-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072051-001SULINDAC200MGTABLET / ORALAB1991-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072051-001SULINDAC200MGTABLET / ORALAB1991-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072051-001SULINDAC200MGTABLET / ORALAB1991-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072051-001SULINDAC200MGTABLET / ORALAB1991-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072051-001SULINDAC200MGTABLET / ORALAB1991-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072051-001SULINDAC200MGTABLET / ORALAB1991-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072051-001SULINDAC200MGTABLET / ORALAB1991-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072051-001SULINDAC200MGTABLET / ORALAB1991-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A072051-001SULINDAC200MGTABLET / ORALAB1991-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072051-001SULINDAC200MGTABLET / ORALAB1991-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072051-001SULINDAC200MGTABLET / ORALAB1991-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072051-001SULINDAC200MGTABLET / ORALAB1991-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072051-001SULINDAC200MGTABLET / ORALAB1991-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A072051-001SULINDAC200MGTABLET / ORALAB1991-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072051-001SULINDAC200MGTABLET / ORALAB1991-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072051-001SULINDAC200MGTABLET / ORALAB1991-04-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A072051-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072051-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072051-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072051-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072051-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072051-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072051-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072051-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072051-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072051-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072051-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072051-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072051-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072051-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072051-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072051-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072051-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072051-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072051-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072051-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072051-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072051-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072051-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072051-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072051-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072051-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072051-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072051-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072051-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072051-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072051-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072051-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072051-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072051-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072051-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072051-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072051-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072051-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072051-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072051-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-211-30EA - Each61919-211a629fe7e-9d2c-4076-bc3b-3285eb0d55ee12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULINDACSULINDACA-S Medication Solutionsf4985b1b-7e2c-4911-897a-94c337794bab2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072051
application number: ANDA072051
SULINDACSULINDACPD-Rx Pharmaceuticals, Inc.1fffe88d-50c8-45cf-ac7c-a62b665c89a82025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072051
application number: ANDA072051
SULINDACSULINDACSun Pharmaceutical Industries, Inc.a47e4259-d44b-4b7b-b517-841cb68409822024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072051
application number: ANDA072051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-211-306191902113030 TABLET in 1 BOTTLE (61919-211-30) 30 tablet2014-04-020000-00-00NoNoCurrent