FDA.reportPublic FDA data

Application 040749

Type
ANDA
Sponsor
THEPHARMANETWORK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL200MGNoYes

Source provenance: Browse the complete Orange Book source catalog.

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 1 · 5 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): 040749
application number: ANDA040749
ndc (product): 71335-0725
BENZONATATEBENZONATATEQPharma, Inc.55c4ae18-3e37-4caf-9fdb-9d307970b5f92025-12-21Warnings, Adverse reactionsExact identifier
ndc (product): 42708-082
BENZONATATEBENZONATATEAscend Laboratories, LLC54374c04-63b9-49fa-b6a2-4a711e322d8e2025-12-02Warnings, Adverse reactionsExact identifier
ndc (product): 67877-575
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
ndc (product): 71205-972
benzonatateBENZONATATEProficient Rx LP27156dad-64d6-4ea4-a3da-29e8e096fb012020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
ndc (product): 71205-037

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-5186benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7186benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7186benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0904-5905benzonatatebenzonatateMAJOR PHARMACEUTICALS INCANDACurrent
10544-094benzonatatebenzonatateBlenheim Pharmacal, Inc.ANDACurrent
10544-123benzonatatebenzonatateBlenheim Pharmacal, Inc.ANDACurrent
10544-129benzonatatebenzonatateBlenheim Pharmacal, Inc.ANDACurrent
21695-760benzonatatebenzonatateRebel Distributors CorpANDACurrent
33261-634benzonatatebenzonatateAidarex Pharmaceuticals LLCANDACurrent
42708-082benzonatatebenzonatateQPharma IncANDACurrent
42708-082benzonatatebenzonatateQPharma IncANDACurrent
42708-107benzonatatebenzonatateQPharma IncANDACurrent
42708-107benzonatatebenzonatateQPharma IncANDACurrent
42708-107benzonatatebenzonatateQPharma IncANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-552benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-3246benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3246benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50436-5996benzonatatebenzonatateUnit Dose ServicesANDACurrent
51655-770BenzonatateBenzonatateNorthwind Pharmaceuticals, LLCANDACurrent
52959-410benzonatatebenzonatateH.J. Harkins Company, Inc.ANDACurrent
53002-0410benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53002-0410benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53002-0412benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53217-338benzonatatebenzonatateAidarex Pharmaceuticals LLCANDACurrent
55700-561benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-561benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-517BENZONATATEBENZONATATEDIRECT RXANDACurrent
61919-517BENZONATATEBENZONATATEDirect_RxANDACurrent
61919-517BENZONATATEBENZONATATEDirect_RxANDACurrent
63629-1052benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-1053benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7647benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7647benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7949benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63739-124benzonatatebenzonatateMcKesson CorporationANDACurrent
67296-0822benzonatatebenzonatateRedPharm Drug Inc.ANDACurrent
67296-1583benzonatatebenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1583benzonatatebenzonatateRedPharm Drug, Inc.ANDACurrent
67877-106benzonatatebenzonatateAscend Laboratories LLCANDACurrent
67877-106benzonatatebenzonatateAscend Laboratories LLCANDACurrent
67877-575benzonatatebenzonatateAscend Laboratories LLCANDACurrent
68071-3185benzonatatebenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4258benzonatatebenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4258benzonatatebenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-9502benzonatatebenzonatatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0043benzonatatebenzonatateREMEDYREPACK INC.ANDACurrent
70518-1338benzonatatebenzonatateREMEDYREPACK INC.ANDACurrent
70518-1338benzonatatebenzonatateREMEDYREPACK INC.ANDACurrent
70934-078benzonatatebenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-078benzonatatebenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-078benzonatatebenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-037benzonatatebenzonatateProficient Rx LPANDACurrent
71205-037benzonatatebenzonatateProficient Rx LPANDACurrent
71205-037benzonatatebenzonatateProficient Rx LPANDACurrent
71205-972benzonatatebenzonatateProficient Rx LPANDACurrent
71205-972benzonatatebenzonatateProficient Rx LPANDACurrent
71335-0725benzonatatebenzonatateBryant Ranch PrepackANDACurrent
71335-0725benzonatatebenzonatateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7678ORIG2007-07-30