Loratadine and Pseudoephedrine Sulfate

Product NDC
37808-724
11-digit product format
378080724
Labeler code
37808
Product ID
37808-724_3e9fe73b-d3ee-4160-8dfa-8b099cd68e8a
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine and pseudoephedrine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
HEB
Application
ANDA076557
Marketing category
ANDA
Marketing start
2018-02-01
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10; 240 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

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
A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine and Pseudoephedrine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1
PSEUDOEPHEDRINE SULFATE240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AJO3BO7QNInternal UNII lookup
Y9DL7QPE6BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1117562Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
74e7670a-5eca-4556-a860-0d36e8561518Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-724-69Loratadine and Pseudoephedrine Sulfate10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37808-724-69EA - Each37808-7241502e9a1-a721-47f0-ae86-b1d4678342f112022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
SHELLACINACTIVE INGREDIENT46N107B71OLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-724LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEB]2Current NDC, Legacy NDC, 1 package rows20180519_74e7670a-5eca-4556-a860-0d36e8561518.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEOhm Laboratories Inc.556b89ef-3b51-4faa-afb4-767a5c1b64222026-06-02WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESportpharm LLC2b432b67-f9f3-45e2-8306-2d4080152f992026-02-06WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
ALLERGY RELIEF-DLORATADINE AND PSEUDOEPHEDRINECVS Pharmacy0b26004d-f741-48e1-bf2b-ec4af81501602025-11-19WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMajor Pharmaceuticals2620a150-4a2c-4fa2-a0e4-6aafe9e496c32025-09-08WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEOhm Laboratories Inc.bbe83464-a582-469f-8fac-f98e804d96fe2025-07-15WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEThe Kroger Company43e53450-9630-4161-8008-22267a7853432025-04-24WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEWAL-MART STORES, INC59453133-20bf-4f13-855a-b47b22302d8b2025-04-14WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLCcdecad62-bf1e-43fb-b4be-8fc54b63e4ae2024-11-22WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLC48bfc938-d97d-4b49-8637-3b00ac8709022024-11-21WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMeijer Distribution, Inc.eb6e2196-2f4f-4fe9-9c80-b4ce89da8db42023-08-23WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended ReleaseLORATADINE AND PSEUDOEPHEDRINE SULFATEKirkland-COSTCO WHOLESALE COMPANYb8e35d9f-5ad7-4cd5-b359-18f7dfe586c62023-08-23WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINESTRATEGIC SOURCING SERVICES LLC07f03186-438d-41b7-a871-f05a387333292023-08-11WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINE SULFATERite Aidbb0f7653-378f-40b1-8ead-77999fcbd87b2022-05-09WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Leader Allergy Relief D-24LORATADINE AND PSEUDOEPHEDRINE SULFATECardinal Healthf1bcd2aa-e8cd-4364-87b4-c544537cdb502022-03-22WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESafeway Inc.c1e1e0ca-30df-4ace-a7b6-c66a3c5ab6762021-12-21WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEWalgreen Companyab7e4406-997a-43be-af99-a07a2da870da2021-08-25WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEAMERISOURCE BERGEN96635cb0-8c78-4c3a-8294-2804ff26f90a2021-06-03WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEAmerisource Bergen3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c12021-06-03WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESTRATEGIC SOURCING SERVICES114b5e7c-973a-4a34-8538-a214de090b392020-07-30WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557
Loratadine and PseudoephedrineLORATADINE AND PSEUDOEPHEDRINEProficient Rx LPca1a6552-d082-4312-ba17-0055e8554eb92019-12-01WarningsExact identifier
application applno (ANDA): 076557
application number: ANDA076557

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN74e7670a-5eca-4556-a860-0d36e85615182
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD74e7670a-5eca-4556-a860-0d36e85615182
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY74e7670a-5eca-4556-a860-0d36e85615182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-724-693780807246910 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (37808-724-69) 2018-02-010000-00-00NoNoCurrent