BENZONATATE

Product NDC
51655-773
11-digit product format
516550773
Labeler code
51655
Product ID
51655-773_ec18e10d-91a1-4d20-8a6b-ddcc5ea9c44c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA040682
Marketing category
ANDA
Marketing start
2015-03-12
Marketing end
0000-00-00
Substance
BENZONATATE
Active strength
200 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-773DDiscontinued by firm2026-08-03
excluded packagepackage51655-77351655-773-20DDiscontinued by firm2026-08-03
excluded packagepackage51655-77351655-773-52DDiscontinued by firm2026-08-03

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 2 · 63 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 packagepackage51655-773-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-773-52d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-773-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-773-52f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-773-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-773-522ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-773-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-773-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-773-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-773-52cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-773-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-773-52cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-773-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-773-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-773-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-773-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-773-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-773-520efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-773-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-773-52ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-773-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-773-52367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-773-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-773-52557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-773-208af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-773-528af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-773-20834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-773-52834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-773-201332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-773-521332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-773-20fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-773-52fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-773-2086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-773-5286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-773-20bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-773-52bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-773-208dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-773-528dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-773-20e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-773-52e2bbac7714bc…27bdfed8d636…

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
A040682-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2007-07-30
A040682-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2007-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040682-001AA
A040682-002AA

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 UTC2026-02A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040682-001BENZONATATE100MGCAPSULE / ORALAA2007-07-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A040682-002BENZONATATE200MGCAPSULE / ORALAA2007-07-30782e0a99824c…

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 UTC2026-02A040682-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040682-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040682-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040682-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040682-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040682-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040682-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040682-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040682-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040682-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040682-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040682-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040682-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040682-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040682-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040682-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040682-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040682-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040682-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040682-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040682-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040682-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040682-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040682-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040682-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040682-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040682-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040682-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040682-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040682-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040682-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040682-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040682-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040682-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040682-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040682-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040682-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040682-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040682-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040682-002AA1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51655-773-202026-01-08BENZONATATE
51655-773-522026-01-08BENZONATATE
51655-773-202020-01-31BENZONATATE
51655-773-522020-01-31BENZONATATE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-773BENZONATATE CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS]2Legacy NDC20150507_b8b7c363-b87d-41e2-8145-7f8004c166db.zip

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
BenzonatateBENZONATATERedpharm Drug4972e1e4-7eac-a770-e063-6294a90abe282026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682
BenzonatateBENZONATATERedpharm Drug46e97547-23d9-114a-e063-6394a90a920b2025-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682
BenzonatateBENZONATATEAmneal Pharmaceuticals LLC199a42ae-4d19-4e68-934d-dabd270849882024-10-23Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682
BenzonatateBENZONATATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f32014c7-bc0c-4edb-b591-7baa6664d74b2024-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682
BenzonatateBENZONATATEChartwell RX, LLC8a17033c-1ad3-4c7a-92ee-f557568339862023-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682
BENZONATATEBENZONATATEBryant Ranch Prepack418c4c4e-6195-4d0d-a559-ee3f10147b5b2023-03-24Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682
BenzonatateBENZONATATEProficient Rx LP19f1e761-69e9-4330-ad3c-1f1180d70cb02021-01-01Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 040682
application number: ANDA040682