FDA.reportPublic FDA data

Guaifenesin and Pseudoephedrine HCL

Product NDC
55111-799
11-digit product format
551110799
Labeler code
55111
Product ID
55111-799_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine HCL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA208369
Marketing category
ANDA
Marketing start
2017-12-29
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1200; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Pseudoephedrine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 6V9V2RYJ8N
Rxcui1244675, 1305603

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
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
55111-799-04Guaifenesin and Pseudoephedrine HCL4 in 1 CARTONTABLET, EXTENDED RELEASE49
55111-799-06Guaifenesin and Pseudoephedrine HCL6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE69
55111-799-12Guaifenesin and Pseudoephedrine HCL12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE129
55111-799-12Guaifenesin and Pseudoephedrine HCL1 in 1 CARTONTABLET, EXTENDED RELEASE19
55111-799-24Guaifenesin and Pseudoephedrine HCL12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE129
55111-799-24Guaifenesin and Pseudoephedrine HCL2 in 1 CARTONTABLET, EXTENDED RELEASE29
55111-799-36Guaifenesin and Pseudoephedrine HCL3 in 1 CARTONTABLET, EXTENDED RELEASE39
55111-799-36Guaifenesin and Pseudoephedrine HCL12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-799-24EA - Each55111-799e4586115-733d-4288-a34c-4dca900065d012019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-799GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]7Current NDC, Legacy NDC, 8 package rows20200312_845a2dcc-9069-3141-ae13-f2063f36d130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN845a2dcc-9069-3141-ae13-f2063f36d1309
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN845a2dcc-9069-3141-ae13-f2063f36d1309
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD845a2dcc-9069-3141-ae13-f2063f36d1309
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD845a2dcc-9069-3141-ae13-f2063f36d1309
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY845a2dcc-9069-3141-ae13-f2063f36d1309
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN19cde6f8-649a-df69-7ee9-05da2cccba5b7
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNf3933531-aa4d-cb67-1895-f2f14175f1d27
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD19cde6f8-649a-df69-7ee9-05da2cccba5b7
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDf3933531-aa4d-cb67-1895-f2f14175f1d27
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN82654829-a2a5-06aa-930c-5bdd60e49b105
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD82654829-a2a5-06aa-930c-5bdd60e49b105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-799-04551110799044 BLISTER PACK in 1 CARTON (55111-799-04) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) 4 blister pack2017-12-290000-00-00NoNoCurrent
55111-799-06551110799066 in 1 BLISTER PACKHistorical
55111-799-12551110799121 BLISTER PACK in 1 CARTON (55111-799-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-12-290000-00-00NoNoCurrent
55111-799-24551110799242 BLISTER PACK in 1 CARTON (55111-799-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-12-290000-00-00NoNoCurrent
55111-799-36551110799363 BLISTER PACK in 1 CARTON (55111-799-36) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2017-12-290000-00-00NoNoCurrent
55111-799-84551110799845 BLISTER PACK in 1 CARTON (55111-799-84) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack29-DEC-17Current