Ibuprofen
- Product NDC
- 62207-356
- 11-digit product format
- 622070356
- Labeler code
- 62207
- Product ID
- 62207-356_44dee7dd-17ff-8faa-e063-6294a90a6712
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Granules India Limited
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-09-21
- Substance
- IBUPROFEN
- Active strength
- 800 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62207-356-42 | Ibuprofen | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 24 |
| 62207-356-43 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 24 |
| 62207-356-47 | Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 24 |
| 62207-356-49 | Ibuprofen | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 24 |
| 62207-356-54 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-356 | IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED] | 23 | Current NDC, Legacy NDC, 5 package rows | 20240719_8804564c-9e1b-43c1-8b58-fd6ace645f00.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62207-356-42 | 62207035642 | 50 TABLET, FILM COATED in 1 BOTTLE (62207-356-42) | 2015-09-21 | 0000-00-00 | No | No | Current |
| 62207-356-43 | 62207035643 | 100 TABLET, FILM COATED in 1 BOTTLE (62207-356-43) | 2015-09-21 | 0000-00-00 | No | No | Current |
| 62207-356-47 | 62207035647 | 500 TABLET, FILM COATED in 1 BOTTLE (62207-356-47) | 2015-09-21 | 0000-00-00 | No | No | Current |
| 62207-356-49 | 62207035649 | 1000 TABLET, FILM COATED in 1 BOTTLE (62207-356-49) | 2015-09-21 | 0000-00-00 | No | No | Current |
| 62207-356-54 | 62207035654 | 30 TABLET, FILM COATED in 1 BOTTLE (62207-356-54) | 2015-09-21 | 0000-00-00 | No | No | Current |