FDA.reportPublic FDA data

Pseudoephedrine Hydrochloride

Product NDC
70000-0164
11-digit product format
700000164
Labeler code
70000
Product ID
70000-0164_2729ed53-f924-47da-b2e8-31fe5851ce90
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA077442
Marketing category
ANDA
Marketing start
2017-02-15
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70000-0164DDiscontinued by firm2026-08-03
excluded packagepackage70000-016470000-0164-1DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077442-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2005-09-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077442-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2005-09-28a50c72e98297…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC3bf95c58-4fd9-4caa-a54f-2e61a5eacae82026-05-06WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESportpharm LLC3b5c81b7-7464-129f-e063-6294a90a48c02026-02-06WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions0a2672f0-4e6f-48c9-8571-2d09f06253d72026-01-29WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals658b0fe8-d564-4f79-bbb2-939c518651b72024-06-18WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
12 Hour Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH0ec510e8-a8cf-474b-9da4-2ac5122d6b492024-05-20WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.4e98dd9f-4ab9-4d95-95b0-799ce217da702024-01-18WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companye33d6ca8-7b3c-42ad-85d3-3302a949501e2022-05-18WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH 110, LLC DBA LEADERa2189d7d-9335-4e96-8f6d-95c583739ac02022-05-12WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEThe Kroger Company00a8327b-41f0-4498-ad13-331256b539f92021-04-13WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC918b2a90-532b-4358-bdff-9ad48c167a7e2020-08-11WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services53acd8d9-b9d8-4a38-8597-32043548d8322020-07-01WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEHEBd9b46ff2-8bde-47c0-bc63-b19dbe7e197b2019-05-29WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.f398ceab-e3d2-421d-813e-b66369f654722019-05-01WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy3a3d11e5-ebbf-4356-8ae6-4e5656b5644c2019-04-10WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Consortium, LLCaec6412a-b62c-44c8-84f5-77f5fa4410282019-04-10WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESAM'S WEST INC5a885a10-7751-44f1-b2d9-a918f27604df2019-03-29WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEDISCOUNT DRUG MART7668ad20-1ca7-4d93-b3a3-03cfde141f862019-03-19WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESafeway Inc.01a5d9dd-f123-443b-b968-412c0aadaaa22019-03-14WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Marketing Association Inc.880d368f-0ce3-4993-b5b1-13bf013105162019-03-14WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc9a6ece8b-7036-4cad-aeb3-993ef4bf614f2019-03-14WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0164-1EA - Each70000-01643f674c9c-8a99-4d86-994d-d537997303e512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0164PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [CARDINAL HEALTH]3Legacy NDC20190327_b8ff40d6-d44c-444e-975f-5fd481578332.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0164-17000001640110 TABLET, EXTENDED RELEASE in 1 CARTON (70000-0164-1) 2017-02-150000-00-00NoNoCurrent