Prescription drug · ANDA

Nifedipine NDC 0904-7208

Nifedipine 30 mg/1 · Tablet, Film coated, Extended release · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7208Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0904-7208-06009047208060090472080650 BLISTER PACK in 1 CARTON (0904-7208-06) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 15, 2015
0904-7208-610090472086100904720861100 BLISTER PACK in 1 CARTON (0904-7208-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 15, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 30 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203126
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 0904-7208_0d78b4c9-7b42-496e-b1c5-74c1d0857b15SPL ID 0d78b4c9-7b42-496e-b1c5-74c1d0857b15SPL set ID b885b6b5-71c6-4799-8b23-5ee8c17938a0RxCUI 1812011UNII I9ZF7L6G2L
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

N400904720806 followed by a unit qualifier and the quantity

Package 00904-7208-06. 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 & USAGE I. Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic comp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7208

What is NDC 0904-7208?
0904-7208 is the product NDC for Nifedipine, Nifedipine 30 mg/1 tablet, film coated, extended release, listed with the FDA by Major Pharmaceuticals. It has 2 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?
Major Pharmaceuticals, NDC labeler code 0904. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nifedipine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralCoupler LLC67046-026067046-0260-03
NifedipineNifedipine 10 mg/1CapsuleOralREMEDYREPACK INC.70518-462570518-4625-00
NifedipineNifedipine 10 mg/1CapsuleOralCardinal Health 107, LLC55154-019655154-0196-00
NifedipineNifedipine 90 mg/1Tablet, Film coated, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-86260760-0862-90
NifedipineNifedipine 60 mg/1Tablet, Film coated, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-85960760-0859-90
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-38651655-0386-52
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-59351655-0593-26
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-73246708-0732-3146708-0732-6346708-0732-91
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-73346708-0733-3146708-0733-63
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-73446708-0734-31

All 128 Nifedipine NDCs

Other NDCs under ANDA 203126

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203126
ProductStrengthForm · routeLabelerProduct NDC
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralProficient Rx LP71205-412
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-010
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-009
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-009
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-010
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-011
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-011
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-738
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-4097
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-9651
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-290
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-990
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1277
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-047
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-048
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-049
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralProficient Rx LP71205-963
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralProficient Rx LP71205-964
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralProficient Rx LP71205-965

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