Home NDC 67544-373 Temazepam
Product NDC 67544-373
11-digit product format 675440373
Labeler code 67544
Product ID 67544-373_100df325-8fc5-4e54-95d9-19c8b1f81a13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temazepam
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA071428
Marketing category ANDA
Marketing start 1988-01-12
Marketing end 0000-00-00
Substance TEMAZEPAM
Active strength 30 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2019-12-31
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 4 · 189 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071428-001 TEMAZEPAM TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071428-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071428-001 TEMAZEPAM 30MG CAPSULE / ORAL AB 1988-01-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 67544-373-10 Temazepam 10 in 1 BOTTLE, PLASTIC CAPSULE 10 2 67544-373-15 Temazepam 15 in 1 BOTTLE, PLASTIC CAPSULE 15 2 67544-373-20 Temazepam 20 in 1 BOTTLE, PLASTIC CAPSULE 20 2 67544-373-28 Temazepam 28 in 1 BOTTLE, PLASTIC CAPSULE 28 2 67544-373-30 Temazepam 30 in 1 BOTTLE, PLASTIC CAPSULE 30 2 67544-373-53 Temazepam 60 in 1 BOTTLE, PLASTIC CAPSULE 60 2 67544-373-59 Temazepam 22 in 1 BOTTLE, PLASTIC CAPSULE 22 2 67544-373-60 Temazepam 90 in 1 BOTTLE, PLASTIC CAPSULE 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TEMAZEPAM ACTIVE INGREDIENT CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TEMAZEPAM ACTIVE MOIETY CHB1QD2QSS TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-373 TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 8 package rows 20130513_a2a65116-b351-4833-8813-c975161dad6a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 67544-373-10 67544037310 10 in 1 BOTTLE, PLASTIC Historical 67544-373-15 67544037315 15 in 1 BOTTLE, PLASTIC Historical 67544-373-20 67544037320 20 in 1 BOTTLE, PLASTIC Historical 67544-373-28 67544037328 28 in 1 BOTTLE, PLASTIC Historical 67544-373-30 67544037330 30 in 1 BOTTLE, PLASTIC Historical 67544-373-53 67544037353 60 in 1 BOTTLE, PLASTIC Historical 67544-373-59 67544037359 22 in 1 BOTTLE, PLASTIC Historical 67544-373-60 67544037360 90 in 1 BOTTLE, PLASTIC Historical