Application 040627

Type
ANDA
Sponsor
THEPHARMANETWORK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL100MGNoYes
002BENZONATATEBENZONATATECAPSULE;ORAL100MGNoYes
003BENZONATATEBENZONATATECAPSULE;ORAL150MGNoYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040627-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2007-03-30
A040627-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2007-07-25
A040627-003BENZONATATEBENZONATATE150MGCAPSULE / ORALAARS2014-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040627-001AA
A040627-002AA
A040627-003AA

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 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-003BENZONATATE150MGCAPSULE / ORALAARS2014-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-301e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040627-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040627-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040627-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040627-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040627-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-002AA103ed91905a0d…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040627-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040627-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040627-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040627-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040627-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040627-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040627-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040627-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040627-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040627-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040627-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040627-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040627-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040627-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040627-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040627-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040627-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040627-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040627-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040627-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040627-001AA1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040627-001AA1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040627-002AA1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040627-003AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040627-001AA13f0d92c62455…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
benzonatateBENZONATATEBryant Ranch Prepacka788cb01-6dc3-4f28-aaa0-c23ac058c39a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATENorthwind Health Company, LLCda807eb3-349e-61b9-e053-2995a90a0e212026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATEQPharma, Inc.55c4ae18-3e37-4caf-9fdb-9d307970b5f92025-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATECoupler LLC463d5cff-3cd6-58fc-e063-6394a90a996b2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATEAscend Laboratories, LLC54374c04-63b9-49fa-b6a2-4a711e322d8e2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
ndc (product): 67877-573
BENZONATATEBENZONATATEDIRECT RX673bf826-a005-7a38-e053-2991aa0a4cb52025-02-17Warnings, Adverse reactionsExact identifier
ndc (product): 61919-573
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
benzonatateBENZONATATEProficient Rx LP9fb78c06-e527-4596-884c-fcf882927a332020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
ndc (product): 63187-928
benzonatateBENZONATATEBryant Ranch Prepack143a5ba8-0ee9-43be-a0da-2c455c1a46bd2019-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 114 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0237benzonatatebenzonatateKAISER FOUNDATION HOSPITALSANDACurrent
0440-1185benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-5185benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7185benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7185benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0615-7887benzonatatebenzonatateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8143benzonatatebenzonatateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8194benzonatatebenzonatateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8194benzonatatebenzonatateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-5904benzonatatebenzonatateMAJOR PHARMACEUTICALS INCANDACurrent
0904-5904benzonatatebenzonatateMajor PharmaceuticalsANDACurrent
0904-6657benzonatatebenzonatateMajor PharmaceuticalsANDACurrent
0904-6657benzonatatebenzonatateMajor PharmaceuticalsANDACurrent
21695-191benzonatatebenzonatateRebel Distributors CorpANDACurrent
33261-147benzonatatebenzonatateAidarex Pharmaceuticals LLCANDACurrent
43063-111benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-798benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-798benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-798benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-798benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-798benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-910benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-910benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-910benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-910benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-297benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0534benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3212benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3212benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3212benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3228benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3228benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-4390benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50436-0573benzonatatebenzonatateUnit Dose ServicesANDACurrent
50436-5995benzonatatebenzonatateUnit Dose ServicesANDACurrent
51655-769BENZONATATEBENZONATATENorthwind Pharmaceuticals, LLCANDACurrent
52959-411benzonatatebenzonatateH.J. Harkins Company, Inc.ANDACurrent
53002-5890benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53002-5890benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53217-342benzonatatebenzonatateAidarex Pharmaceuticals LLCANDACurrent
55154-4686benzonatatebenzonatateCardinal HealthANDACurrent
55154-6849benzonatatebenzonatateCardinal HealthANDACurrent
55289-175benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-556benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-346benzonatatebenzonatateAmerican Health PackagingANDACurrent
60687-346benzonatatebenzonatateAmerican Health PackagingANDACurrent
60687-346benzonatatebenzonatateAmerican Health PackagingANDACurrent
60760-051benzonatatebenzonatateSt Marys Medical Park PharmacyANDACurrent
60760-573benzonatatebenzonatateSt. Mary's Medical Park PharmacyANDACurrent
60760-573benzonatatebenzonatateSt. Mary's Medical Park PharmacyANDACurrent
61919-031BENZONATATEBENZONATATEDIRECT RXANDACurrent
61919-031BENZONATATEBENZONATATEDIRECT RXANDACurrent
61919-573BENZONATATEBENZONATATEDIRECT RXANDACurrent
61919-573BENZONATATEBENZONATATEDirect_RxANDACurrent
61919-573BENZONATATEBENZONATATEDirect_RxANDACurrent
61919-573BENZONATATEBENZONATATEDirect_RxANDACurrent
63187-016benzonatatebenzonatateProficient Rx LPANDACurrent
63187-016benzonatatebenzonatateProficient Rx LPANDACurrent
63187-185benzonatatebenzonatateProficient Rx LPANDACurrent
63187-185benzonatatebenzonatateProficient Rx LPANDACurrent
63187-928benzonatatebenzonatateProficient Rx LPANDACurrent
63187-928benzonatatebenzonatateProficient Rx LPANDACurrent
63187-928benzonatatebenzonatateProficient Rx LPANDACurrent
63629-1050benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-1050benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-1051benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7632benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7632benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7976benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63739-029benzonatatebenzonatateMcKesson Corporation dba SKY PackagingANDACurrent
63739-029benzonatatebenzonatateMcKesson Corporation dba SKY PackagingANDACurrent
63739-029benzonatatebenzonatateMcKesson CorporationANDACurrent
67296-0581benzonatatebenzonatateRedPharm Drug Inc.ANDACurrent
67296-1566benzonatatebenzonatateRedPharm Drug, INc.ANDACurrent
67296-1566benzonatatebenzonatateRedPharm Drug, INc.ANDACurrent
67296-1788benzonatatebenzonatateRedPharm Drug, Inc.ANDACurrent
67877-105benzonatatebenzonatateAscend Laboratories LLCANDACurrent
67877-105benzonatatebenzonatateAscend Laboratories LLCANDACurrent
67877-573benzonatatebenzonatateAscend Laboratories LLCANDACurrent
68071-1891benzonatatebenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent