Application 040682

Type
ANDA
Sponsor
ORIT LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL100MGNoNo
002BENZONATATEBENZONATATECAPSULE;ORAL200MGNoNo

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…

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
ndc (product): 65162-537
ndc (product): 65162-536
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
ndc (product): 62135-441
ndc (product): 62135-440
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
ndc (product): 63187-076

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-632BenzonatateBenzonatateMarlex Pharmaceuticals IncANDACurrent
12634-826BenzonatateBenzonatateApotheca Inc.ANDACurrent
35356-863BenzonatateBenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
42254-078BenzonatateBenzonatateRebel Distributors CorpANDACurrent
42291-164BenzonatateBenzonatateAvKARE, Inc.ANDACurrent
42291-164BenzonatateBenzonatateAvKAREANDACurrent
42291-165BenzonatateBenzonatateAvKARE, Inc.ANDACurrent
42708-015BenzonatateBenzonatateQPharma IncANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0532BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-0533BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-0872BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
51655-772BENZONATATEBENZONATATENorthwind Pharmaceuticals, LLCANDACurrent
51655-773BENZONATATEBENZONATATENorthwind PharmaceuticalsANDACurrent
55700-922BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
55700-922BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
55700-923BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
55700-923BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
61919-272BenzonatateBenzonatateDirect RXANDACurrent
61919-325BENZONATATEBENZONATATEDirectRXANDACurrent
62135-440BenzonatateBenzonatateChartwell RX, LLCANDACurrent
62135-441BenzonatateBenzonatateChartwell RX, LLCANDACurrent
62332-426BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-426BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-426BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-427BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-427BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-427BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
63187-076BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-076BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-076BenzonatateBenzonatateProficient Rx LPANDACurrent
63629-6690BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-6690BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
64205-536BenzonatateBenzonatateReadyMedsANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
66116-487BenzonatateBenzonatateMedVantx, Inc.ANDACurrent
67296-0567BenzonatateBenzonatateRedPharm Drug Inc.ANDACurrent
67296-1768BENZONATATEBENZONATATERedPharm Drug, Inc.ANDACurrent
67296-1768BENZONATATEBENZONATATERedPharm Drug, Inc.ANDACurrent
68151-2697BenzonatateBenzonatateCarilion Materials ManagementANDACurrent
68788-8127BENZONATATEBENZONATATEPreferred Pharmaceuticals Inc.ANDACurrent
68788-9827BenzonatateBenzonatatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0008BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent
70518-0837BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent
70518-0837BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent