Diclofenac Sodium
- Product NDC
- 55700-834
- 11-digit product format
- 557000834
- Labeler code
- 55700
- Product ID
- 55700-834_46f2b119-efcd-497d-aefc-74029d190313
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 2020-01-03
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-834-20 | 2025-01-13 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-30 | 2025-01-13 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-60 | 2025-01-13 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-90 | 2025-01-13 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
| 55700-834-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-c5f8-0266-e053-dadaa90a7c1a | cb3e7228-e0ae-49b8-ab2a-d2f3cbd2892e |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-834-20 | EA - Each | 55700-834 | a7f86123-54b0-4a2b-9979-b8d74570c291 | 1 | 2020-03-10 |
| 55700-834-30 | EA - Each | 55700-834 | 2355a6e4-cfa0-492a-b7bf-456790bf6c29 | 1 | 2020-03-10 |
| 55700-834-60 | EA - Each | 55700-834 | 03e93695-33f0-48a2-b774-d747cf460862 | 1 | 2020-03-10 |
| 55700-834-90 | EA - Each | 55700-834 | 65e2b8bd-41c7-4cc7-9cd1-d1da9c366722 | 1 | 2021-03-02 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-834-20 | 55700083420 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-20) | 2020-01-03 | 0000-00-00 | No | No | Current |
| 55700-834-30 | 55700083430 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-30) | 2020-01-03 | 0000-00-00 | No | No | Current |
| 55700-834-60 | 55700083460 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-60) | 2020-01-03 | 0000-00-00 | No | No | Current |
| 55700-834-90 | 55700083490 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-90) | 2021-01-15 | 0000-00-00 | No | No | Current |