Ibuprofen
- Product NDC
- 53943-115
- 11-digit product format
- 539430115
- Labeler code
- 53943
- Product ID
- 53943-115_f5312ee8-5fef-4c62-af83-0f8ef81bdd53
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Discount Drug Mart
- Application
- ANDA091237
- Marketing category
- ANDA
- Marketing start
- 2013-06-20
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53943-115-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-12ac-f424-e053-dadaa90a57ce | f5312ee8-5fef-4c62-af83-0f8ef81bdd53 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53943-115-01 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 53943-115-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET [DISCOUNT DRUG MART] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | f5312ee8-5fef-4c62-af83-0f8ef81bdd53 | 1 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | f5312ee8-5fef-4c62-af83-0f8ef81bdd53 | 1 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | f5312ee8-5fef-4c62-af83-0f8ef81bdd53 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53943-115-01 | 53943011501 | 1 in 1 CARTON | Historical |