Acunistat-30
- Product NDC
- 70529-010
- 11-digit product format
- 705290010
- Labeler code
- 70529
- Product ID
- 70529-010_ad05f182-8be9-4012-999d-f1f73f5df50d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride, Ketorolac Tromethamine
- Dosage form
- KIT
- Labeler
- IT3 Medical LLC
- Application
- ANDA088299
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| 6a38bd75-79e3-96c0-1204-08a0282902ae | Product name | 4 | 20250128 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 4d6e22a5-3693-6edf-0179-2ab93aecbadb | Product name | 9 | 20240724 |
| 03452e68-2506-686e-a908-f2381c778fc6 | Product name | 5 | 20240307 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| bb41bc3a-c643-93c9-055f-a8f48f363af3 | Product name | 2 | 20190219 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c | Product name | 1 | 20140508 |
| 8d3e992f-8ff7-c106-f7eb-1e2d5eb12025 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70529-010-01 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-6bd9-a426-e053-dadaa90af4c2 | Acunistat-30 Injection System |
| 70529-010-01 | 2022-03-01 | C162847 | 48780-1 | d6a99b39-6bd9-a426-e053-dadaa90af4c2 | Acunistat-30 Injection System |
| 70529-010-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6bd9-a426-e053-dadaa90af4c2 | Acunistat-30 Injection System |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70529-010-01 | Acunistat-30 | 1 in 1 PACKAGE | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 1010033 | lidocaine HCl 1 % Injectable Solution | PSN | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 1010033 | lidocaine hydrochloride 10 MG/ML Injectable Solution | SCD | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
| 1010033 | lidocaine hydrochloride 1 % Injectable Solution | SY | fad54f13-52a6-4c4b-9120-46bfffe2808e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70529-010-01 | 70529001001 | 1 KIT in 1 PACKAGE (70529-010-01) * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 PACKET * 50 mL in 1 VIAL, MULTI-DOSE | 1 kit | 2017-03-01 | 0000-00-00 | No | No | Current |