Seizalam

Product NDC
11704-650
Requested package NDC
11704-650-10
11-digit product format
117040650
Labeler code
11704
Product ID
11704-650_5b6fdc8f-162b-4873-a70e-2a674064dca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Meridian Medical Technologies LLC
Application
NDA209566
Marketing category
NDA
Marketing start
2018-09-14
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11704-65011704-650-10DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11704-65011704-650-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209566-001SEIZALAMMIDAZOLAM HYDROCHLORIDEEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD2018-09-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD2018-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD2018-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD2018-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-143f01610625f2…
2019-09-15 20:21 UTC2019-09N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209566-001SEIZALAMEQ 50MG BASE/10ML (EQ 5MG BASE/ML)SOLUTION / INTRAMUSCULARRLD, RS2018-09-14cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209566-001ODE-2072025-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N209566-001ODE-2072025-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209566-001ODE-2072025-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209566-001ODE-2072025-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209566-001ODE-2072025-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209566-001ODE-2072025-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209566-001ODE-2072025-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209566-001ODE-2072025-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209566-001ODE-2072025-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209566-001ODE-2072025-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209566-001ODE-2072025-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209566-001ODE-2072025-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209566-001ODE-2072025-09-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209566-001ODE-2072025-09-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209566-001ODE-2072025-09-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209566-001ODE-2072025-09-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209566-001ODE-2072025-09-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209566-001ODE-2072025-09-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209566-001ODE-2072025-09-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209566-001ODE-2072025-09-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N209566-001ODE-2072025-09-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209566-001ODE-2072025-09-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209566-001ODE-2072025-09-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209566-001ODE-2072025-09-143f01610625f2…
2019-09-15 20:21 UTC2019-09N209566-001ODE-2072025-09-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N209566-001ODE-2072025-09-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209566-001ODE-2072025-09-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209566-001ODE-2072025-09-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209566-001ODE-2072025-09-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209566-001ODE-2072025-09-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209566-001ODE-2072025-09-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209566-001ODE-2072025-09-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209566-001ODE-2072025-09-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N209566-001ODE-2072025-09-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N209566-001ODE-2072025-09-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209566-001ODE-2072025-09-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209566-001ODE-2072025-09-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209566-001ODE-2072025-09-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209566-001ODE-2072025-09-14cb3db0bc1861…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11704-650SEIZALAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [MERIDIAN MEDICAL TECHNOLOGIES LLC ]12Legacy NDC20230129_cb2381bf-984a-48a8-95c0-3017c34cc170.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11704-650-101170406501010 VIAL, GLASS in 1 CARTON (11704-650-10) > 10 mL in 1 VIAL, GLASS (11704-650-01) 2018-09-140000-00-00NoNoCurrent