IBUPROFEN

Product NDC
62207-320
11-digit product format
622070320
Labeler code
62207
Product ID
62207-320_44a726e4-0a4b-b303-e063-6394a90a9073
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Limited
Application
ANDA202312
Marketing category
ANDA
Marketing start
2019-11-14
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPROFEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-320-41IBUPROFEN24 in 1 BOTTLETABLET246
62207-320-42IBUPROFEN50 in 1 BOTTLETABLET506
62207-320-43IBUPROFEN100 in 1 BOTTLETABLET1006
62207-320-46IBUPROFEN250 in 1 BOTTLETABLET2506
62207-320-47IBUPROFEN500 in 1 BOTTLETABLET5006
62207-320-48IBUPROFEN750 in 1 BOTTLETABLET7506
62207-320-49IBUPROFEN1000 in 1 BOTTLETABLET10006
62207-320-89IBUPROFEN10 in 1 BOTTLETABLET106
62207-320-90IBUPROFEN1700 in 1 BOTTLETABLET17006
62207-320-91IBUPROFEN160000 in 1 DRUMTABLET1600006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-320IBUPROFEN TABLET [GRANULES INDIA LIMITED]5Current NDC, Legacy NDC, 10 package rows20230131_97516b9f-219a-429d-850d-1fe9fd66646b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN97516b9f-219a-429d-850d-1fe9fd66646b6
310965ibuprofen 200 MG Oral TabletSCD97516b9f-219a-429d-850d-1fe9fd66646b6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY97516b9f-219a-429d-850d-1fe9fd66646b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-320-416220703204124 TABLET in 1 BOTTLE (62207-320-41) 24 tablet2019-11-140000-00-00NoNoCurrent
62207-320-426220703204250 TABLET in 1 BOTTLE (62207-320-42) 50 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4362207032043100 TABLET in 1 BOTTLE (62207-320-43) 100 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4662207032046250 TABLET in 1 BOTTLE (62207-320-46) 250 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4762207032047500 TABLET in 1 BOTTLE (62207-320-47) 500 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4862207032048750 TABLET in 1 BOTTLE (62207-320-48) 750 tablet2019-11-140000-00-00NoNoCurrent
62207-320-49622070320491000 TABLET in 1 BOTTLE (62207-320-49) 1000 tablet2019-11-140000-00-00NoNoCurrent
62207-320-896220703208910 TABLET in 1 BOTTLE (62207-320-89) 10 tablet2020-12-030000-00-00NoNoCurrent
62207-320-90622070320901700 TABLET in 1 BOTTLE (62207-320-90) 1700 tablet2020-12-030000-00-00NoNoCurrent
62207-320-9162207032091160000 TABLET in 1 DRUM (62207-320-91) 160000 tablet2019-11-140000-00-00NoNoCurrent