Prescription drug · ANDA
Nifedipine NDC 68382-690
Nifedipine 90 mg/1 · Tablet, Extended release · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-690-01 | 6838206900168382069001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-01)Marketed from Aug 18, 2018 | |
| 68382-690-10 | 6838206901068382069010 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-10)Marketed from Aug 18, 2018 | |
| 68382-690-16 | 6838206901668382069016 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-16)Marketed from Aug 18, 2018 | |
| 68382-690-77 | 6838206907768382069077 | 10 BLISTER PACK in 1 CARTON (68382-690-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 18, 2018 | |
| 68382-690-95 | 6838206909568382069095 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-95)Marketed from Aug 18, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nifedipine
- Generic name (nonproprietary)
- nifedipine
- Active ingredients
- Nifedipine — 90 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210184
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68382-690_18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45SPL ID 18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45SPL set ID 1c857df2-9cce-40de-95c3-b1274ed1e1bcRxCUI 198034, 198035, 198036UNII I9ZF7L6G2LUPC 0368382688774, 0368382690777
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468382069001followed by a unit qualifier and the quantityPackage 68382-0690-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
About NDC 68382-690
- What is NDC 68382-690?
- 68382-690 is the product NDC for Nifedipine, Nifedipine 90 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nifedipine.
- What is the active ingredient?
- Nifedipine.
- Who is the labeler?
- Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nifedipine?
- 127 other product NDCs are listed under this name. See all Nifedipine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nifedipine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-0260 | 67046-0260-03 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4625 | 70518-4625-00 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0196 | 55154-0196-00 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-862 | 60760-0862-90 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-859 | 60760-0859-90 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-386 | 51655-0386-52 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-593 | 51655-0593-26 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-732 | 46708-0732-3146708-0732-6346708-0732-91 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-733 | 46708-0733-3146708-0733-63 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-734 | 46708-0734-31 |
Other NDCs under ANDA 210184
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-688 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-689 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1365 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1366 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1367 |