Midazolam Injection
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sagent Pharmaceuticals (2012-09-12)
- Oldest Current Product
- 2000-06-21
- License(s)
- ANDA
- RxNORM
- INJECTION\MIDAZOLAM
- FDAOB
- INJECTION\INJECTION\MIDAZOLAM HYDROCHLORIDE\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\MIDAZOLAM HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\MIDAZOLAM HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\MIDAZOLAM HYDROCHLORIDE
INTRAVENOUS\INJECTION\MIDAZOLAM HYDROCHLORIDE - SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\MIDAZOLAM
INTRAMUSCULAR\INJECTION\MIDAZOLAM
INTRAVENOUS\INJECTION, SOLUTION\MIDAZOLAM
INTRAVENOUS\INJECTION\MIDAZOLAM
product(s) by strength(s)
midazolam 1 mg/ml injection
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 004092305 | ANDA | Hospira, Inc. | 2002-07-22 | MIDAZOLAM HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075857 | 1abda8b8-48a8-4995-af86-39220d1aa240 |
2 | 250210655 | ANDA | Sagent Pharmaceuticals | 2012-03-19 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA090315 | e22611dd-1830-40af-9139-7cdb07f5a426 |
invalid application product(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 556480764 | ANDA | Wockhardt Limited | 2008-11-10 | MIDAZOLAM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA078511 | c94e8384-28b1-4668-95fe-3202497490ae |
2 | 646790764 | ANDA | Wockhardt Usa Llc. | 2008-11-10 | MIDAZOLAM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA078511 | c9c15206-e694-42f2-af87-9c115de2ce37 |
2 ml midazolam 1 mg/ml injection
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 576640633 | ANDA | Caraco Pharmaceutical Laboratories, Ltd. | 2012-08-08 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION | ANDA090696 | 809095f5-c2a8-434d-b319-28ab4e7d29f2 |
relabeler product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 551540352 | ANDA | Cardinal Health | 2000-06-21 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION | 553900137 | ANDA075421 | df469447-4d34-4c6b-b203-4f16e7c638b8 |
2 | 551544743 | ANDA | Cardinal Health | 2002-07-22 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 004092305 | ANDA075857 | cbedf0bf-82a4-4214-96d5-01ac35e101f0 |
relabeler product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 551544734 | ANDA | Cardinal Health | 2002-07-22 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 004092305 | ANDA075857 | 3e25ee1f-01d6-4651-9b1c-b2b69bf51e8c |
midazolam 5 mg/ml injection
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 004092308 | ANDA | Hospira, Inc. | 2002-07-22 | MIDAZOLAM HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075857 | 1abda8b8-48a8-4995-af86-39220d1aa240 |
2 | 250210656 | ANDA | Sagent Pharmaceuticals | 2012-03-19 | MIDAZOLAM HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA090315 | e22611dd-1830-40af-9139-7cdb07f5a426 |
relabeler product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 525840308 | ANDA | General Injecatables & Vaccines, Inc | 2010-08-01 | MIDAZOLAM HYDROCHLORIDE | INTRAVENOUS | INJECTION | 004092308 | ANDA075857 | d6de628c-bbe5-437e-9338-6f54cd661be1 |
relabeler product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 551540359 | ANDA | Cardinal Health | 2000-06-21 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION | 553900138 | ANDA075421 | df469447-4d34-4c6b-b203-4f16e7c638b8 |
2 | 682588973 | ANDA | Dispensing Solutions, Inc. | 2011-05-02 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 004092308 | ANDA075857 | 9a0664f8-323e-4960-b1ad-36fd667b3e19 |
relabeler product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 551540354 | ANDA | Cardinal Health | 2000-06-21 | MIDAZOLAM HYDROCHLORIDE | INTRAMUSCULAR | INJECTION | 553900138 | ANDA075421 | 4f092ea9-e411-4936-8fe3-b219b1276aee |
application(s)
application drug(s)
# | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
---|---|---|---|---|---|---|---|---|
1 | ANDA075154_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
2 | ANDA075154_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
3 | ANDA075243_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
4 | ANDA075243_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
5 | ANDA075247_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-23 | MIDAZOLAM HYDROCHLORIDE |
6 | ANDA075247_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2000-06-23 | MIDAZOLAM HYDROCHLORIDE |
7 | ANDA075249_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-06-23 | MIDAZOLAM HYDROCHLORIDE | |
8 | ANDA075263_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-06-26 | MIDAZOLAM HYDROCHLORIDE | |
9 | ANDA075293_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | True | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
10 | ANDA075293_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | True | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
11 | ANDA075324_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
12 | ANDA075324_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
13 | ANDA075396_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE | |
14 | ANDA075396_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE | |
15 | ANDA075409_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE | |
16 | ANDA075409_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE | |
17 | ANDA075421_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
18 | ANDA075421_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE |
19 | ANDA075455_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE | |
20 | ANDA075481_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-30 | MIDAZOLAM HYDROCHLORIDE |
21 | ANDA075484_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-06-20 | MIDAZOLAM HYDROCHLORIDE | |
22 | ANDA075494_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2000-06-30 | MIDAZOLAM HYDROCHLORIDE |
23 | ANDA075494_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-06-30 | MIDAZOLAM HYDROCHLORIDE |
24 | ANDA075620_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2000-11-01 | MIDAZOLAM HYDROCHLORIDE | |
25 | ANDA075620_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-11-01 | MIDAZOLAM HYDROCHLORIDE | |
26 | ANDA075637_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2000-10-31 | MIDAZOLAM HYDROCHLORIDE | |
27 | ANDA075637_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-10-31 | MIDAZOLAM HYDROCHLORIDE | |
28 | ANDA075641_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2000-10-19 | MIDAZOLAM HYDROCHLORIDE | |
29 | ANDA075856_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2002-06-13 | MIDAZOLAM HYDROCHLORIDE |
30 | ANDA075856_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2002-06-13 | MIDAZOLAM HYDROCHLORIDE |
31 | ANDA075857_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | True | AP | 2002-07-22 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
32 | ANDA075857_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | True | AP | 2002-07-22 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
33 | ANDA076020_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2004-07-16 | MIDAZOLAM HYDROCHLORIDE | |
34 | ANDA076020_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2004-07-16 | MIDAZOLAM HYDROCHLORIDE | |
35 | ANDA076144_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2005-01-26 | MIDAZOLAM HYDROCHLORIDE | |
36 | ANDA076144_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2005-01-26 | MIDAZOLAM HYDROCHLORIDE | |
37 | ANDA078141_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2008-05-30 | MIDAZOLAM HYDROCHLORIDE | |
38 | ANDA078141_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2008-05-30 | MIDAZOLAM HYDROCHLORIDE | |
39 | ANDA078511_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 2008-11-10 | MIDAZOLAM HYDROCHLORIDE | |
40 | ANDA078511_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 2008-11-10 | MIDAZOLAM HYDROCHLORIDE | |
41 | ANDA090315_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2010-11-29 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
42 | ANDA090315_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2010-11-29 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
43 | ANDA090316_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2011-05-04 | MIDOZALAM HYDROCHLORIDE |
44 | ANDA090316_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2011-05-04 | MIDOZALAM HYDROCHLORIDE |
45 | ANDA090696_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2012-02-29 | MIDAZOLAM HYDROCHLORIDE |
46 | ANDA090850_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2012-01-25 | MIDAZOLAM HYDROCHLORIDE |
47 | ANDA203460_001 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | AP | 2014-08-22 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
48 | ANDA203460_002 | RX | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2014-08-22 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
49 | NDA018654_001 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | 1985-12-20 | VERSED | |
50 | NDA018654_002 | discontinued | MIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML) | INJECTION | False | 1987-05-26 | VERSED |
spl(s)
# | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
---|---|---|---|---|---|---|---|---|---|---|
1 | 1abda8b8-48a8-4995-af86-39220d1aa240 (view SPL) | MidazolamInjection, USP | prescription | Human Prescription | Hospira, Inc. | 2012-07-18 | 13 | 004092305, 004092308 | ||
2 | 3e25ee1f-01d6-4651-9b1c-b2b69bf51e8c (view SPL) | MidazolamInjection, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-09-04 | 1 | 551544734 | |
3 | 4f092ea9-e411-4936-8fe3-b219b1276aee (view SPL) | MIDAZOLAM HYDROCHLORIDE INJECTION | prescription | Human Prescription | Cardinal Health | REPACK | 2013-05-16 | 1 | 551540354 | |
4 | 809095f5-c2a8-434d-b319-28ab4e7d29f2 (view SPL) | MIDAZOLAM Injection, USP | prescription | Human Prescription | Caraco Pharmaceutical Laboratories, Ltd. | ANALYSIS, MANUFACTURE, PACK | 2013-06-14 | 3 | 576640633 | |
5 | 9a0664f8-323e-4960-b1ad-36fd667b3e19 (view SPL) | MidazolamInjection, USP | prescription | Human Prescription | Dispensing Solutions, Inc. | relabel, repack | 2012-02-09 | 1 | 682588973 | |
6 | c94e8384-28b1-4668-95fe-3202497490ae (view SPL) | MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV | prescription | Human Prescription | Wockhardt Limited | ANALYSIS, LABEL, MANUFACTURE, PACK | 2012-11-08 | 1 | 556480764 | |
7 | c9c15206-e694-42f2-af87-9c115de2ce37 (view SPL) | MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV | prescription | Human Prescription | Wockhardt Usa Llc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2012-11-08 | 1 | 646790764 | |
8 | cbedf0bf-82a4-4214-96d5-01ac35e101f0 (view SPL) | MidazolamInjection, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-09-19 | 1 | 551544743 | |
9 | d6de628c-bbe5-437e-9338-6f54cd661be1 (view SPL) | Preservative-FreeMidazolam Injection, USPCIVRx Only | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2012-11-01 | 5 | 525840308 | ||
10 | df469447-4d34-4c6b-b203-4f16e7c638b8 (view SPL) | MIDAZOLAM HYDROCHLORIDE INJECTION | prescription | Human Prescription | Cardinal Health | REPACK | 2013-05-16 | 2 | 551540352, 551540359, 551540353 | Midazolam Injectable Solution |
11 | e22611dd-1830-40af-9139-7cdb07f5a426 (view SPL) | Midazolam Injection, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2012-09-12 | 10 | 250210655, 250210656 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII