Clonazepam

Product NDC
67544-256
11-digit product format
675440256
Labeler code
67544
Product ID
67544-256_fc1cc6f8-043d-4908-8529-b1cadc0a85a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074569
Marketing category
ANDA
Marketing start
1996-09-17
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-256DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-15DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-30DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-45DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-53DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-55DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-60DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-70DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-75DDiscontinued by firm2026-08-17
excluded packagepackage67544-25667544-256-80DDiscontinued by firm2026-08-17

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 2 · 120 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-256-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-256-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-752ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-256-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-256-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-75cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-256-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-75cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-256-53cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074569-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB1996-09-10
A074569-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB1996-09-10
A074569-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB1996-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074569-001AB
A074569-002AB
A074569-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074569-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074569-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074569-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074569-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074569-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-256-15EA - Each67544-25620aba6af-ea8b-4b06-9acb-d0c61bd2801d12018-05-09
67544-256-30EA - Each67544-256f21b10da-4f3d-4e45-8d7e-e53f3090eff812018-07-03
67544-256-45EA - Each67544-2562bf8cebe-585d-4c3a-9958-73cdcc34598c12018-07-03
67544-256-53EA - Each67544-2563c96be47-293f-4308-b15d-532f53def59912018-07-03
67544-256-55EA - Each67544-25679d822f9-cfd6-4771-bb8b-5876f1f818fc12018-07-03
67544-256-60EA - Each67544-256c9d176a8-9b12-4c57-b8c4-51c8b19a769b12018-07-03
67544-256-70EA - Each67544-25635d4c417-c7d4-4f28-8c16-ab748f2e541212018-07-03
67544-256-75EA - Each67544-2565b6b9824-89ba-4dd3-afe0-243b7e26b1c512018-07-03
67544-256-80EA - Each67544-256b6791d2f-c81d-455d-9579-d91f7ec98d7112018-07-03

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.64bb2cdf-f57d-4a41-a5bf-ee77b6e64d062026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMCoupler LLC54d6e348-4c51-221e-e063-6294a90a9b7d2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMREMEDYREPACK INC.b1c53213-9f84-4389-b6dc-3dc26d9a63642026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMA-S Medication Solutionsb3c9d04a-431f-4cec-a809-847dfb8de7362024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMClinical Solutions Wholesale, LLC429a15d1-1675-42cc-97f1-c49b037474162024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC73125f86-ce24-44c0-a2b1-a5d12a607a942023-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC6be64dc3-3748-477c-8800-2c2175309c732023-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMTeva Pharmaceuticals USA, Inc.8069b1a0-7c06-4252-b44e-e2eef065d9b82023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMProficient Rx LP56175c25-3fde-43ea-89bf-22dcf3278b6b2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-256-156754402561515 TABLET in 1 BOTTLE (67544-256-15) 15 tablet2018-03-060000-00-00NoNoCurrent
67544-256-306754402563030 TABLET in 1 BOTTLE (67544-256-30) 30 tablet2018-03-060000-00-00NoNoCurrent
67544-256-456754402564545 TABLET in 1 BOTTLE (67544-256-45) 45 tablet2018-03-060000-00-00NoNoCurrent
67544-256-536754402565360 TABLET in 1 BOTTLE (67544-256-53) 60 tablet2018-03-060000-00-00NoNoCurrent
67544-256-556754402565575 TABLET in 1 BOTTLE (67544-256-55) 75 tablet2018-03-060000-00-00NoNoCurrent
67544-256-606754402566090 TABLET in 1 BOTTLE (67544-256-60) 90 tablet2018-03-060000-00-00NoNoCurrent
67544-256-7067544025670120 TABLET in 1 BOTTLE (67544-256-70) 120 tablet2018-03-060000-00-00NoNoCurrent
67544-256-7567544025675150 TABLET in 1 BOTTLE (67544-256-75) 150 tablet2018-03-060000-00-00NoNoCurrent
67544-256-8067544025680180 TABLET in 1 BOTTLE (67544-256-80) 180 tablet2018-03-060000-00-00NoNoCurrent