NDC 21695-014-60 - Baclofen
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 21695-014
- Requested NDC
- 21695-014-60
- Package NDCs from labels
- 21695-014-30, 21695-014-42, 21695-014-60, 21695-014-90, 21695-014-72
- Manufacturer
- Rebel Distributors Corp.
- Effective date
- 2009-12-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Baclofen Tablets USP 10mg & 20mg | Rebel Distributors Corp. | 2009-12-01 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-014-42 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c6e-48b1-e053-8cdaa90a720a | Baclofen Tablets USP 10mg & 20mg |
| 21695-014-72 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c6e-48b1-e053-8cdaa90a720a | Baclofen Tablets USP 10mg & 20mg |
| 21695-014-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c6e-48b1-e053-8cdaa90a720a | Baclofen Tablets USP 10mg & 20mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-014-30 | Baclofen | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-014-42 | Baclofen | 42 in 1 BOTTLE | TABLET | 42 | 1 | |
| 21695-014-60 | Baclofen | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 21695-014-72 | Baclofen | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 21695-014-90 | Baclofen | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-014-30 | EA - Each | 21695-014 | 045b5479-8a48-4d8c-9230-f5d2a183b569 | 1 | 2012-07-24 |
| 21695-014-60 | EA - Each | 21695-014 | f974850f-d5fd-43d0-8ba4-4c7e7a277577 | 1 | 2012-07-24 |
| 21695-014-72 | EA - Each | 21695-014 | 67d2f2c6-d0bc-41c7-872b-eb0966b54255 | 1 | 2012-07-24 |
| 21695-014-90 | EA - Each | 21695-014 | 10ba6395-b45c-47ec-8f19-96e039588df3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.] | 1 |
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 |
|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | ee59a379-17d5-487f-b72f-a53e74744a70 | 2026-03-27 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 91175128-8285-4d04-89a9-219781be9260 | 2026-03-25 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 16266972-843e-4ea5-be1f-fb1b1588a5dc | 2026-03-25 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 0a1d09ac-94d5-45ef-92cc-bc261c2b2d75 | 2026-03-25 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 4f84b27a-725a-48e6-a58a-85bbb395f4ae | 2026-03-23 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | d20cc8b2-5236-4c87-b395-0acaaf7b62dd | 2026-03-19 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 5f6a86f9-9658-4210-a47c-62907edfd416 | 2026-03-19 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | 5e479876-adfb-4590-ac10-3924ff7988b0 | 2026-03-18 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | 3fdfeef9-68b3-4f6c-a4de-28179758a962 | 2026-03-18 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Redpharm Drug | 4ce1de84-72e1-57d3-e063-6294a90a220f | 2026-03-13 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| OZOBAX DS | BACLOFEN | Rosemont Pharmaceuticals LLC | d8ddcec5-debe-42b4-a803-e65917cc6a54 | 2026-03-13 | Warnings, Adverse reactions | H789N3FKE8 |
| Leader Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Cardinal Health | 5c5d6c13-9b51-48f0-8627-b60b0f707fd3 | 2026-03-12 | Warnings | FZ989GH94E |
| Baclofen | BACLOFEN | Lifestar Pharma LLC | f9dd1b55-2984-446a-8146-2ab0f5211e15 | 2026-02-27 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 7ee42a29-21c2-47f8-a5b3-f3af115b665d | 2026-02-24 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Major Pharmaceuticals | 46f84504-ffc4-4be5-9598-c20a3f4210f4 | 2026-02-13 | Warnings, Adverse reactions | H789N3FKE8 |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Sportpharm LLC | 8d58dcbb-72a0-41f0-9eeb-613072a6d7ae | 2026-02-06 | Warnings | FZ989GH94E |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80b0a41e-2cad-4e14-9605-0cd35f9991e9 | 2026-02-05 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 7df6e691-f1d5-441c-b5bb-a3867983e09f | 2026-02-05 | Warnings, Adverse reactions | H789N3FKE8 |
| MINIDROPS | LUBRICANT EYE DROPS | Optics Laboratory, Inc | c13c5f91-50df-471c-a7c9-1747a2ac1250 | 2026-02-03 | Warnings | FZ989GH94E |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals, Inc. | 58416ceb-994f-4571-afbd-c2171823f528 | 2026-01-26 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.