Ketalar
- Product NDC
- 42023-113
- 11-digit product format
- 420230113
- Labeler code
- 42023
- Product ID
- 42023-113_00836cdd-f898-4031-85f8-bb58a63b1a9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketamine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Par Health USA, LLC
- Application
- NDA016812
- Marketing category
- NDA
- Marketing start
- 2007-10-01
- Substance
- KETAMINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016812-001 | KETALAR | KETAMINE HYDROCHLORIDE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N016812-002 | KETALAR | KETAMINE HYDROCHLORIDE | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | |
| N016812-003 | KETALAR | KETAMINE HYDROCHLORIDE | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N016812-001 | AP |
| N016812-002 | AP |
| N016812-003 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016812-002 | KETALAR | EQ 50MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016812-003 | KETALAR | EQ 100MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016812-001 | KETALAR | EQ 10MG BASE/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016812-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016812-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N016812-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N016812-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016812-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N016812-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N016812-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016812-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N016812-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016812-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016812-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016812-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N016812-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016812-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N016812-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016812-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016812-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016812-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016812-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016812-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016812-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016812-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016812-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016812-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016812-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016812-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016812-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016812-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016812-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016812-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016812-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016812-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016812-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N016812-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N016812-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N016812-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016812-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016812-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016812-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016812-001 | AP | 1 | 301d65b070ca… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketalar
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| KETAMINE HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| O18YUO0I83 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 14e8f864-8b8a-4e7e-8439-e510d3107063 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42023-113-10 | Ketalar | 20 mL in 1 VIAL | INJECTION | 20 | 33 | |
| 42023-113-10 | Ketalar | 10 in 1 CARTON | INJECTION | 10 | 33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42023-113-10 | ML - Milliliter | 42023-113 | 37e2f9c5-a7d3-45c4-bd1b-18da6eba0b55 | 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 |
|---|---|---|---|---|---|---|
| Ketalar | KETAMINE HYDROCHLORIDE | Par Health USA, LLC | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 2026-03-27 | Warnings, Adverse reactions | 016812 NDA016812 42023-113 |
| KETALAR | KETAMINE HYDROCHLORIDE | Henry Schein, Inc | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 2025-01-27 | Warnings, Adverse reactions | 016812 NDA016812 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 206967 | Ketalar 10 MG/ML Injectable Solution | PSN | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206970 | Ketalar 100 MG/ML Injectable Solution | PSN | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206972 | Ketalar 50 MG/ML Injectable Solution | PSN | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238082 | ketamine 10 MG/ML Injectable Solution | PSN | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238083 | ketamine 100 MG/ML Injectable Solution | PSN | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238084 | ketamine 50 MG/ML Injectable Solution | PSN | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206967 | ketamine 10 MG/ML Injectable Solution [Ketalar] | SBD | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206970 | ketamine 100 MG/ML Injectable Solution [Ketalar] | SBD | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206972 | ketamine 50 MG/ML Injectable Solution [Ketalar] | SBD | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238082 | ketamine 10 MG/ML Injectable Solution | SCD | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238083 | ketamine 100 MG/ML Injectable Solution | SCD | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238084 | ketamine 50 MG/ML Injectable Solution | SCD | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206967 | Ketalar (ketamine hydrochloride) 10 MG/ML Injectable Solution | SY | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206970 | Ketalar (ketamine hydrochloride) 100 MG/ML Injectable Solution | SY | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206972 | Ketalar (ketamine hydrochloride) 50 MG/ML Injectable Solution | SY | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238082 | ketamine (as ketamine hydrochloride) 10 MG/ML Injectable Solution | SY | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238083 | ketamine (as ketamine hydrochloride) 100 MG/ML Injectable Solution | SY | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 238084 | ketamine (as ketamine hydrochloride) 50 MG/ML Injectable Solution | SY | 14e8f864-8b8a-4e7e-8439-e510d3107063 | 33 |
| 206967 | Ketalar 10 MG/ML Injectable Solution | PSN | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 5 |
| 238082 | ketamine 10 MG/ML Injectable Solution | PSN | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 5 |
| 206967 | ketamine 10 MG/ML Injectable Solution [Ketalar] | SBD | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 5 |
| 238082 | ketamine 10 MG/ML Injectable Solution | SCD | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 5 |
| 206967 | Ketalar (ketamine hydrochloride) 10 MG/ML Injectable Solution | SY | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 5 |
| 238082 | ketamine (as ketamine hydrochloride) 10 MG/ML Injectable Solution | SY | 46dab560-8ecd-4d92-8c92-6baa2310b09b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42023-113-10 | 42023011310 | 10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL | 10 vial | 2007-10-01 | 0000-00-00 | No | No | Current |