FDA.reportPublic FDA data

Guaifenesin 1200 mg

Product NDC
43598-009
11-digit product format
435980009
Labeler code
43598
Product ID
43598-009_cdb94f95-f037-62cc-0d37-2b8c5ea26ca4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA215932
Marketing category
ANDA
Marketing start
2022-03-15
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin 1200 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621, 636522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-009-25Guaifenesin 1200 mg2 in 1 CARTONTABLET, EXTENDED RELEASE26
43598-009-37Guaifenesin 1200 mg3 in 1 CARTONTABLET, EXTENDED RELEASE36
43598-009-74Guaifenesin 1200 mg14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-009GUAIFENESIN 600 MG (GUAIFENESIN ) TABLET, EXTENDED RELEASE GUAIFENESIN 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC, 3 package rows20240727_99307c61-5df3-0a83-1e21-ddb03bc905b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN99307c61-5df3-0a83-1e21-ddb03bc905b46
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN99307c61-5df3-0a83-1e21-ddb03bc905b46
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD99307c61-5df3-0a83-1e21-ddb03bc905b46
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD99307c61-5df3-0a83-1e21-ddb03bc905b46
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY99307c61-5df3-0a83-1e21-ddb03bc905b46
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY99307c61-5df3-0a83-1e21-ddb03bc905b46
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN525fda90-134c-f038-c403-eb5ffc1fb1f14
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN525fda90-134c-f038-c403-eb5ffc1fb1f14
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD525fda90-134c-f038-c403-eb5ffc1fb1f14
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD525fda90-134c-f038-c403-eb5ffc1fb1f14
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY525fda90-134c-f038-c403-eb5ffc1fb1f14
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY525fda90-134c-f038-c403-eb5ffc1fb1f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-009-10435980009101000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10)15-MAR-22Current
43598-009-25435980009252 BLISTER PACK in 1 CARTON (43598-009-25) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) 2 blister pack2022-03-150000-00-00NoNoCurrent
43598-009-37435980009373 BLISTER PACK in 1 CARTON (43598-009-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) 3 blister pack2022-09-01NoNoCurrent
43598-009-744359800097414 in 1 BLISTER PACKHistorical