INDOMETHACIN ER is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc.. The primary component is Indomethacin.
Product ID | 12634-838_543aa8e5-219e-41d8-8ffa-9ae1446d3391 |
NDC | 12634-838 |
Product Type | Human Prescription Drug |
Proprietary Name | INDOMETHACIN ER |
Generic Name | Indomethacin |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2006-05-02 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA074464 |
Labeler Name | Apotheca, Inc. |
Substance Name | INDOMETHACIN |
Active Ingredient Strength | 75 mg/1 |
Pharm 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 |
Marketing Start Date | 2006-05-02 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA074464 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-05-02 |
Inactivation Date | 2020-01-31 |
Ingredient | Strength |
---|---|
INDOMETHACIN | 75 mg/1 |
SPL SET ID: | 6569dfd1-0164-4241-b508-ccd540d1e858 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
PHarm Class EPC | |
NUI Code |
NDC | Brand Name | Generic Name |
---|---|---|
12634-160 | INDOMETHACIN ER | INDOMETHACIN |
12634-838 | INDOMETHACIN ER | INDOMETHACIN |
42211-101 | INDOCIN | indomethacin |
42211-102 | INDOCIN | Indomethacin |
0185-0720 | Indomethacin | Indomethacin |
0378-0143 | Indomethacin | indomethacin |
0378-0147 | Indomethacin | indomethacin |
0409-1113 | Indomethacin | Indomethacin |
0440-1652 | Indomethacin | indomethacin |
0713-0176 | INDOMETHACIN | INDOMETHACIN |
10544-083 | Indomethacin | Indomethacin |
10544-216 | Indomethacin | indomethacin |
10544-234 | Indomethacin | indomethacin |
10544-919 | Indomethacin | Indomethacin |
10544-935 | Indomethacin | Indomethacin |
10702-016 | INDOMETHACIN | Indomethacin |
21695-522 | Indomethacin | Indomethacin |
21695-523 | Indomethacin | Indomethacin |
23155-010 | Indomethacin | Indomethacin |
23155-011 | Indomethacin | Indomethacin |
31722-542 | Indomethacin | Indomethacin |
31722-543 | Indomethacin | Indomethacin |
31722-565 | Indomethacin | Indomethacin |
33261-133 | Indomethacin | indomethacin |
35356-697 | Indomethacin | Indomethacin |
42254-081 | Indomethacin | Indomethacin |
42254-237 | INDOMETHACIN | indomethacin |
42708-030 | indomethacin | indomethacin |
43063-368 | Indomethacin | Indomethacin |
42211-201 | Tivorbex | indomethacin |
42211-202 | Tivorbex | indomethacin |