RESTORIL
- Product NDC
- 0406-9917
- Requested package NDC
- 0406-9917-01
- 11-digit product format
- 004069917
- Labeler code
- 0406
- Product ID
- 0406-9917_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
- 30 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018163-001 | RESTORIL | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N018163-002 | RESTORIL | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | |
| N018163-003 | RESTORIL | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 |
| N018163-004 | RESTORIL | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018163-001 | AB |
| N018163-002 | AB |
| N018163-003 | AB |
| N018163-004 | 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.
| 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 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-001 | RESTORIL | 15MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-002 | RESTORIL | 30MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-003 | RESTORIL | 7.5MG | CAPSULE / ORAL | AB | RLD | 1991-10-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-004 | RESTORIL | 22.5MG | CAPSULE / ORAL | AB | RLD | 2004-11-02 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018163-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018163-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018163-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018163-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018163-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018163-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018163-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018163-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018163-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018163-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018163-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018163-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018163-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RESTORIL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TEMAZEPAM | 30 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| CHB1QD2QSS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bc56f7fd-1aaf-48ff-8aa7-d467e59e1015 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a3aa44f1-a660-94b4-7185-b48df8b066ff | Product name | 5 | 20250522 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-9917-01 | RESTORIL | 100 in 1 BOTTLE | CAPSULE | 100 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-9917-01 | EA - Each | 0406-9917 | af6a35e1-0d9b-4f27-a712-b1b0b073c9c3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RESTORIL | TEMAZEPAM | SpecGx LLC | bc56f7fd-1aaf-48ff-8aa7-d467e59e1015 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 018163 NDA018163 0406-9917-01 0406-9917 00406991701 |
| TEMAZEPAM | TEMAZEPAM | SpecGx LLC | c9bc61b4-a579-4003-98da-b6f6e381c150 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 018163 NDA018163 |
| Temazepam | TEMAZEPAM | American Health Packaging | a3f06243-fa03-4cbd-951a-144ec43dcdfd | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | 018163 NDA018163 |
| TEMAZEPAM | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 97afda58-4daf-4192-bd87-3ccbb000ee52 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 018163 NDA018163 |
| TEMAZEPAM | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | a8deb28b-c5a3-4775-8bec-3f276698d064 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 018163 NDA018163 |
| TEMAZEPAM | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1 | 2019-03-26 | Boxed warning, Warnings, Adverse reactions | 018163 NDA018163 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-9917-01 | 00406991701 | 100 CAPSULE in 1 BOTTLE (0406-9917-01) | 100 capsule | 1981-02-27 | 0000-00-00 | No | No | Current |