Home NDC 67544-117-60 Oxazepam
Product NDC 67544-117
Requested package NDC 67544-117-60
11-digit product format 675440117
Labeler code 67544
Product ID 67544-117_166ba137-98a4-4072-90e1-ab7b6248a351
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxazepam
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA072251
Marketing category ANDA
Marketing start 2007-01-02
Marketing end 0000-00-00
Substance OXAZEPAM
Active strength 10 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 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog .
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67544-117-30 Oxazepam 30 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 30 3 67544-117-53 Oxazepam 60 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 60 3 67544-117-60 Oxazepam 90 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 90 3 67544-117-70 Oxazepam 120 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 120 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXAZEPAM ACTIVE INGREDIENT 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 OXAZEPAM ACTIVE MOIETY 6GOW6DWN2A OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-117 OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC, 4 package rows 20191224_3bccbfa9-fdcf-44c3-86f5-028ca92223ca.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67544-117-60 67544011760 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-60) 2007-01-22 0000-00-00 No No Current