Ibuprofen
- Product NDC
- 21695-420
- 11-digit product format
- 216950420
- Labeler code
- 21695
- Product ID
- 21695-420_07f01136-4649-4c5d-93c5-a8a7dbced9a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076925
- Marketing category
- ANDA
- Marketing start
- 2004-09-23
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | 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 |
|---|---|---|---|---|---|
| 21695-420-12 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b84-48b1-e053-8cdaa90a720a | Ibuprofen Suspension 100 mg/5 mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-420-12 | Ibuprofen | 120 mL in 1 BOTTLE | SUSPENSION | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-420-12 | ML - Milliliter | 21695-420 | f5bb92cb-bbb2-4f11-a440-4128465e4f80 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197803 | ibuprofen 100 MG in 5 mL Oral Suspension | PSN | 07f01136-4649-4c5d-93c5-a8a7dbced9a1 | 1 |
| 197803 | ibuprofen 20 MG/ML Oral Suspension | SCD | 07f01136-4649-4c5d-93c5-a8a7dbced9a1 | 1 |
| 197803 | ibuprofen 100 MG per 5 ML Oral Suspension | SY | 07f01136-4649-4c5d-93c5-a8a7dbced9a1 | 1 |
| 197803 | ibuprofen 200 MG per 10 ML Oral Suspension | SY | 07f01136-4649-4c5d-93c5-a8a7dbced9a1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-420-12 | 21695042012 | 120 mL in 1 BOTTLE | 120 ml | Historical |