IBUPROFEN
- Product NDC
- 12634-171
- 11-digit product format
- 126340171
- Labeler code
- 12634
- Product ID
- 12634-171_36fc14a6-4944-4e90-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2008-11-20
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET [APOTHECA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-171 | IBUPROFEN TABLET [APOTHECA INC.] | 7 | Legacy NDC, 28 package rows | 20160706_0396bfec-afe1-460c-8141-e8ad877b4bc0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-171-00 | 12634017100 | 10 in 1 BOTTLE | Historical |
| 12634-171-01 | 12634017101 | 100 in 1 BOTTLE | Historical |
| 12634-171-09 | 12634017109 | 35 in 1 BOTTLE | Historical |
| 12634-171-40 | 12634017140 | 40 in 1 BOTTLE | Historical |
| 12634-171-42 | 12634017142 | 42 in 1 BOTTLE | Historical |
| 12634-171-50 | 12634017150 | 50 in 1 BOTTLE | Historical |
| 12634-171-52 | 12634017152 | 12 in 1 BLISTER PACK | Historical |
| 12634-171-54 | 12634017154 | 14 in 1 BLISTER PACK | Historical |
| 12634-171-57 | 12634017157 | 20 in 1 BLISTER PACK | Historical |
| 12634-171-59 | 12634017159 | 30 in 1 BLISTER PACK | Historical |
| 12634-171-60 | 12634017160 | 60 in 1 BOTTLE | Historical |
| 12634-171-61 | 12634017161 | 10 in 1 BLISTER PACK | Historical |
| 12634-171-63 | 12634017163 | 3 in 1 BLISTER PACK | Historical |
| 12634-171-66 | 12634017166 | 6 in 1 BLISTER PACK | Historical |
| 12634-171-67 | 12634017167 | 7 in 1 BLISTER PACK | Historical |
| 12634-171-69 | 12634017169 | 9 in 1 BLISTER PACK | Historical |
| 12634-171-71 | 12634017171 | 30 in 1 BOTTLE | Historical |
| 12634-171-74 | 12634017174 | 24 in 1 BOTTLE | Historical |
| 12634-171-78 | 12634017178 | 28 in 1 BOTTLE | Historical |
| 12634-171-79 | 12634017179 | 25 in 1 BOTTLE | Historical |
| 12634-171-80 | 12634017180 | 20 in 1 BOTTLE | Historical |
| 12634-171-81 | 12634017181 | 21 in 1 BOTTLE | Historical |
| 12634-171-82 | 12634017182 | 12 in 1 BOTTLE | Historical |
| 12634-171-85 | 12634017185 | 15 in 1 BOTTLE | Historical |
| 12634-171-91 | 12634017191 | 1 in 1 BLISTER PACK | Historical |
| 12634-171-94 | 12634017194 | 4 in 1 BOTTLE | Historical |
| 12634-171-95 | 12634017195 | 5 in 1 BOTTLE | Historical |
| 12634-171-96 | 12634017196 | 6 in 1 BOTTLE | Historical |