RESTORIL

Product NDC
0406-9915
Requested package NDC
0406-9915-03
11-digit product format
004069915
Labeler code
0406
Product ID
0406-9915_300ed63a-6bbc-4dbd-ba1d-e4eda4737e09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA018163
Marketing category
NDA
Marketing start
1981-02-27
Substance
TEMAZEPAM
Active strength
7.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018163-001RESTORILTEMAZEPAM15MGCAPSULE / ORALABRLD, Approved before 1982
N018163-002RESTORILTEMAZEPAM30MGCAPSULE / ORALABRLD, RS, Approved before 1982
N018163-003RESTORILTEMAZEPAM7.5MGCAPSULE / ORALABRLD1991-10-25
N018163-004RESTORILTEMAZEPAM22.5MGCAPSULE / ORALABRLD2004-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N018163-001AB
N018163-002AB
N018163-003AB
N018163-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018163-001RESTORIL15MGCAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018163-002RESTORIL30MGCAPSULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018163-003RESTORIL7.5MGCAPSULE / ORALABRLD1991-10-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N018163-004RESTORIL22.5MGCAPSULE / ORALABRLD2004-11-02d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018163-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018163-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018163-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018163-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018163-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018163-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018163-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018163-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018163-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018163-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018163-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018163-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018163-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018163-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018163-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018163-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018163-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018163-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018163-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
RESTORIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CHB1QD2QSSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198241Internal RxNorm lookup
198242Internal RxNorm lookup
198243Internal RxNorm lookup
208463Internal RxNorm lookup
208464Internal RxNorm lookup
208465Internal RxNorm lookup
485489Internal RxNorm lookup
539384Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc56f7fd-1aaf-48ff-8aa7-d467e59e1015Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-9915-01RESTORIL100 in 1 BOTTLECAPSULE10024
0406-9915-03RESTORIL30 in 1 BOTTLECAPSULE3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-9915-01EA - Each0406-9915acb0a1b8-4f10-4d65-9165-a5ff6c1ea38812012-07-24
0406-9915-03EA - Each0406-9915423fdb48-3458-42f4-85d7-1d6b0d1dcb2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
ETHYL ACETATEINACTIVE INGREDIENT76845O8NMZRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71ORESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-9915RESTORIL (TEMAZEPAM) CAPSULE [SPECGX LLC]24Current NDC, Legacy NDC, 2 package rows20240517_bc56f7fd-1aaf-48ff-8aa7-d467e59e1015.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RESTORILTEMAZEPAMSpecGx LLCbc56f7fd-1aaf-48ff-8aa7-d467e59e10152026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018163
application number: NDA018163
ndc (package): 0406-9915-03
ndc (product): 0406-9915
ndc11 (package): 00406991503
TEMAZEPAMTEMAZEPAMSpecGx LLCc9bc61b4-a579-4003-98da-b6f6e381c1502026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018163
application number: NDA018163
TemazepamTEMAZEPAMAmerican Health Packaginga3f06243-fa03-4cbd-951a-144ec43dcdfd2025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018163
application number: NDA018163
TEMAZEPAMTEMAZEPAMPD-Rx Pharmaceuticals, Inc.97afda58-4daf-4192-bd87-3ccbb000ee522025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018163
application number: NDA018163
TEMAZEPAMTEMAZEPAMAphena Pharma Solutions - Tennessee, LLCa8deb28b-c5a3-4775-8bec-3f276698d0642024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018163
application number: NDA018163
TEMAZEPAMTEMAZEPAMAphena Pharma Solutions - Tennessee, LLC405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc12019-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018163
application number: NDA018163

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208464Restoril 15 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
539384Restoril 22.5 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208465Restoril 30 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208463Restoril 7.5 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
198241temazepam 15 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
485489temazepam 22.5 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
198242temazepam 30 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
198243temazepam 7.5 MG Oral CapsulePSNbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208464temazepam 15 MG Oral Capsule [Restoril]SBDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
539384temazepam 22.5 MG Oral Capsule [Restoril]SBDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208465temazepam 30 MG Oral Capsule [Restoril]SBDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208463temazepam 7.5 MG Oral Capsule [Restoril]SBDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
198241temazepam 15 MG Oral CapsuleSCDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
485489temazepam 22.5 MG Oral CapsuleSCDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
198242temazepam 30 MG Oral CapsuleSCDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
198243temazepam 7.5 MG Oral CapsuleSCDbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208464Restoril 15 MG Oral CapsuleSYbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
539384Restoril 22.5 MG Oral CapsuleSYbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208465Restoril 30 MG Oral CapsuleSYbc56f7fd-1aaf-48ff-8aa7-d467e59e101524
208463Restoril 7.5 MG Oral CapsuleSYbc56f7fd-1aaf-48ff-8aa7-d467e59e101524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-9915-030040699150330 CAPSULE in 1 BOTTLE (0406-9915-03) 30 capsule1981-02-270000-00-00NoNoCurrent