INDOMETHACIN ER
- Product NDC
- 12634-838
- 11-digit product format
- 126340838
- Labeler code
- 12634
- Product ID
- 12634-838_543aa8e5-219e-41d8-8ffa-9ae1446d3391
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- INDOMETHACIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotheca, Inc.
- Application
- ANDA074464
- Marketing category
- ANDA
- Marketing start
- 2006-05-02
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| INDOMETHACIN | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| ETHYLCELLULOSE | INACTIVE INGREDIENT | 7Z8S9VYZ4B | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| SODIUM LAURETH SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-838 | INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] | 2 | Legacy NDC, 19 package rows | 20100419_6569dfd1-0164-4241-b508-ccd540d1e858.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-838-00 | 12634083800 | 10 in 1 BOTTLE | Historical |
| 12634-838-50 | 12634083850 | 50 in 1 BOTTLE | Historical |
| 12634-838-54 | 12634083854 | 14 in 1 BLISTER PACK | Historical |
| 12634-838-55 | 12634083855 | 15 in 1 BLISTER PACK | Historical |
| 12634-838-57 | 12634083857 | 20 in 1 BLISTER PACK | Historical |
| 12634-838-59 | 12634083859 | 30 in 1 BLISTER PACK | Historical |
| 12634-838-60 | 12634083860 | 60 in 1 BOTTLE | Historical |
| 12634-838-61 | 12634083861 | 10 in 1 BLISTER PACK | Historical |
| 12634-838-66 | 12634083866 | 6 in 1 BLISTER PACK | Historical |
| 12634-838-67 | 12634083867 | 7 in 1 BLISTER PACK | Historical |
| 12634-838-71 | 12634083871 | 30 in 1 BOTTLE | Historical |
| 12634-838-79 | 12634083879 | 25 in 1 BOTTLE | Historical |
| 12634-838-80 | 12634083880 | 20 in 1 BOTTLE | Historical |
| 12634-838-84 | 12634083884 | 14 in 1 BOTTLE | Historical |
| 12634-838-85 | 12634083885 | 15 in 1 BOTTLE | Historical |
| 12634-838-90 | 12634083890 | 90 in 1 BOTTLE | Historical |
| 12634-838-91 | 12634083891 | 1 in 1 BLISTER PACK | Historical |
| 12634-838-95 | 12634083895 | 5 in 1 BOTTLE | Historical |
| 12634-838-97 | 12634083897 | 7 in 1 BOTTLE | Historical |